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Advising mothers about breastfeeding and weaning reduced pacifier use in the first year of life: a randomized trial Feldens CA, Ardenghi TM, Cruz LN, Scalco G, V ıtolo MR. Advising mothers about breastfeeding and weaning reduced pacifier use in the first year of life: a randomized trial. Community Dent Oral Epidemiol 2013; 41: 317–326. © 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd Abstract Objective: To assess the effectiveness of home visits for advising mothers about breastfeeding and weaning on pacifier use in the first year of life. Method: A randomized field trial was conducted on mothers who gave birth within the public health system in the Brazilian city of Sao Leopoldo (intervention group = 200; controls = 300). The intervention group received the advice 10 days after the child’s birth, monthly up to 6 months, at 8, 10, and 12 months, based on the ‘Ten Steps for Healthy Feeding’, a Brazilian national health policy for primary care, which follows WHO guidelines. Relative risk (RR) was used to estimate the effects of the intervention on the risk of using a pacifier. Results: 55.4% of the children in the intervention group and 66.1% of the controls used a pacifier in the first year of life. The risk of using a pacifier was 16% lower for the intervention group (RR = 0.84; 95% CI, 0.710.99). A multivariable Poisson regression model showed higher adjusted risk of using a pacifier for children who had breastfeeding interrupted in the first month of life (RR = 1.43; 95% CI, 1.211.69) and whose mothers presented higher level of depression (RR = 1.40; 95% CI, 1.171.66). Conclusions: Pacifier use is highly prevalent in the population studied. The home visits for dietary advice appear to help in reducing pacifier use in infants. These findings suggest the need for public health strategies that address early advice on pacifier use to promote child oral and general health. Carlos Alberto Feldens 1 , Thiago Machado Ardenghi 2 , Luciane Nascimento Cruz 3 , Giovana Pereira da Cunha Scalco 4 and Ma ´rcia Regina V ıtolo 5 1 Department of Paediatric Dentistry, Universidade Luterana do Brasil, Canoas, Brazil, 2 Department of Stomatology, Universidade Federal de Santa Maria, Santa Maria, Brazil, 3 Health Technology Assessment Institute, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, 4 Department of Preventive and Social Dentistry, Universidade Federal do Rio Grande do Sul Porto Alegre, Brazil, 5 Center for Research in Nutrition, Universidade Federal de Cie ˆncias da Sau ´ de de Porto Alegre, Porto Alegre, Brazil Key words: breastfeeding; infant; pacifier; maternal depression; randomized controlled trial Carlos A. Feldens, Department of Paediatric Dentistry, Universidade Luterana do Brasil, Rua Jo~ ao Telles, 185/1301, Porto Alegre, Rio Grande do Sul 90035-121, Brazil Tel.: +55 51 33115688 Fax: +55 51 33113502 e-mail: [email protected] Submitted 13 February 2012; accepted 6 November 2012 Prevalence data about pacifier use have been pub- lished worldwide, demonstrating a large variation among countries and communities. Data from official Brazilian publications show that 42.6% of children living in state capitals had used the paci- fier in the first year of life (1). Pacifier use has been associated with malocclusion (29), speech disor- der (10), increased incidence of acute otitis media (11), and other infections (12), as well as shorter breastfeeding duration (1319). The World Health Organization strongly discourages use of pacifiers because of its interference with breastfeeding (20). The Brazilian Ministry of Health, supported by the Pan American Health Organization, has estab- lished breastfeeding and healthy weaning as a public health priority (21). Our implementation of the Brazilian Program ‘Ten Steps to Healthy Feed- ing’, based on home visits providing nutritional advice for the first year of life to families from low socioeconomic settings, reduced the incidence of diarrhea (22), respiratory disease symptoms (23), and early childhood caries (24), although not affecting the occurrence of anemia and low height- for-age. doi: 10.1111/cdoe.12030 317 Community Dent Oral Epidemiol 2013; 41; 317–326 All rights reserved Ó 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

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Page 1: Advising mothers about breastfeeding and weaning reduced pacifier use in the first year of life: a randomized trial

Advising mothers aboutbreastfeeding and weaningreduced pacifier use in the firstyear of life: a randomized trial

Feldens CA, Ardenghi TM, Cruz LN, Scalco G, V�ıtolo MR. Advising mothersabout breastfeeding and weaning reduced pacifier use in the first year of life: arandomized trial. Community Dent Oral Epidemiol 2013; 41: 317–326. © 2012John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Abstract – Objective: To assess the effectiveness of home visits for advisingmothers about breastfeeding and weaning on pacifier use in the first year oflife. Method: A randomized field trial was conducted on mothers who gavebirth within the public health system in the Brazilian city of Sao Leopoldo(intervention group = 200; controls = 300). The intervention group received theadvice 10 days after the child’s birth, monthly up to 6 months, at 8, 10, and12 months, based on the ‘Ten Steps for Healthy Feeding’, a Brazilian nationalhealth policy for primary care, which follows WHO guidelines. Relative risk(RR) was used to estimate the effects of the intervention on the risk of using apacifier. Results: 55.4% of the children in the intervention group and 66.1% ofthe controls used a pacifier in the first year of life. The risk of using a pacifierwas 16% lower for the intervention group (RR = 0.84; 95% CI, 0.71–0.99). Amultivariable Poisson regression model showed higher adjusted risk of using apacifier for children who had breastfeeding interrupted in the first month of life(RR = 1.43; 95% CI, 1.21–1.69) and whose mothers presented higher level ofdepression (RR = 1.40; 95% CI, 1.17–1.66). Conclusions: Pacifier use is highlyprevalent in the population studied. The home visits for dietary advice appearto help in reducing pacifier use in infants. These findings suggest the need forpublic health strategies that address early advice on pacifier use to promotechild oral and general health.

Carlos Alberto Feldens1, ThiagoMachado

Ardenghi2, Luciane Nascimento Cruz3,

Giovana Pereira da Cunha Scalco4 and

Marcia Regina V�ıtolo5

1Department of Paediatric Dentistry,

Universidade Luterana do Brasil, Canoas,

Brazil, 2Department of Stomatology,

Universidade Federal de Santa Maria, Santa

Maria, Brazil, 3Health Technology

Assessment Institute, Universidade Federal

do Rio Grande do Sul, Porto Alegre, Brazil,4Department of Preventive and Social

Dentistry, Universidade Federal do Rio

Grande do Sul Porto Alegre, Brazil, 5Center

for Research in Nutrition, Universidade

Federal de Ciencias da Saude de Porto

Alegre, Porto Alegre, Brazil

Key words: breastfeeding; infant; pacifier;maternal depression; randomized controlledtrial

Carlos A. Feldens, Department of PaediatricDentistry, Universidade Luterana do Brasil,Rua Jo~ao Telles, 185/1301, Porto Alegre, RioGrande do Sul 90035-121, BrazilTel.: +55 51 33115688Fax: +55 51 33113502e-mail: [email protected]

Submitted 13 February 2012;accepted 6 November 2012

Prevalence data about pacifier use have been pub-

lished worldwide, demonstrating a large variation

among countries and communities. Data from

official Brazilian publications show that 42.6% of

children living in state capitals had used the paci-

fier in the first year of life (1). Pacifier use has been

associated with malocclusion (2–9), speech disor-

der (10), increased incidence of acute otitis media

(11), and other infections (12), as well as shorter

breastfeeding duration (13–19). The World Health

Organization strongly discourages use of pacifiers

because of its interference with breastfeeding (20).

The Brazilian Ministry of Health, supported by

the Pan American Health Organization, has estab-

lished breastfeeding and healthy weaning as a

public health priority (21). Our implementation of

the Brazilian Program ‘Ten Steps to Healthy Feed-

ing’, based on home visits providing nutritional

advice for the first year of life to families from low

socioeconomic settings, reduced the incidence of

diarrhea (22), respiratory disease symptoms (23),

and early childhood caries (24), although not

affecting the occurrence of anemia and low height-

for-age.

doi: 10.1111/cdoe.12030 317

Community Dent Oral Epidemiol 2013; 41; 317–326All rights reserved

� 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Page 2: Advising mothers about breastfeeding and weaning reduced pacifier use in the first year of life: a randomized trial

It is possible that preventive home visits may

also reduce the early use of pacifier. A theoretical

explanation of the link between preventive home

visits and use of pacifier focuses on the effect of

this strategy to achieve sustainable continuous

breastfeeding practices. This indirect model pro-

poses that the effect of preventive home visits on

the overall duration of breastfeeding will also dis-

courage the early use of pacifiers once previous

studies demonstrate the positive impact of breast-

feeding practices on this outcome (13). However,

to our knowledge, no study has investigated the

effectiveness of programs that aim to advise moth-

ers on the reduction of pacifier use in developing

countries.

This randomized field trial was part of a much

larger study, which was conducted to assess the

impact of home visits for advising mothers about

breastfeeding and weaning on children’s feeding

practices and general health in the early years of

life. This article presents the effectiveness of the

intervention in reducing pacifier use in the first

year of life. Risk factors for using a pacifier in these

children are also presented.

Materials and methods

Subjects and study designThe trial (registered with ClinicalTrials.gov, num-

ber NCT00629629) was conducted in mothers who

gave birth under the public health system in S~ao

Leopoldo, Brazil, to an apparently normal, single,

full-term (� 37 weeks) baby with birth weight

equal or greater than 2500 g, and who did not have

an impediment to breastfeeding (HIV/AIDS).

Mothers giving birth under the public health

system in Southern Brazil are usually from low

socioeconomic background. The city of S~ao Leo-

poldo has a population of about 200,000.

The sample size was previously calculated con-

sidering the main objective of the major project—improvement of the duration of exclusive breast-

feeding—but not the primary outcome of this arti-

cle. A sample of 350 one-year-old children was

estimated in the larger study to detect the effect of

the intervention during the first year. Then, allow-

ing for confounding and losses of 25% during the

follow-up, 500 children were recruited at the outset

of the trial (at birth).

Figure 1 presents the trial profile. A researcher

not directly involved in the selection process

(MRV) conducted the randomization and assign-

ments of two fifth of the mothers to the interven-

tion group (n = 200) and the others to the control

group (n = 300). The mothers who had agreed to

participate were sequentially included in a list

based on time of delivery and then grouped in

blocks of five. Two mothers from each block were

randomly assigned to the intervention group, with

the process being repeated for consecutive blocks.

A larger control group was chosen to increase the

study power with a reasonably small increase in

the costs of the study.

Refused to participate (n = 59)

Assessed for eligibility (n = 559)

Randomized (n = 500)

Allocated to control (n = 300)

Started the follow up (n = 272) Did not start the follow up: address not found (n = 28)

Allocated to intervention (n = 200) Received allocated intervention

(n = 197) Did not receive allocated

intervention: address not found (n = 3)

Lost to follow up (n = 34) Reasons:

Refusal (12); moving to another city (19); child death (1); child given for

adoption (1); maternal illness (1)

Lost to follow up (n = 38) Reasons:

Refusal (10); moving to another city (24); genetic illness (2); child death

(1); maternal death (1)

One year assessment Dietary behaviour variables (n = 163)

Pacifier use data (n = 157)Analised (n = 157)

One year assessment Dietary behaviour variables (n = 234)

Pacifier use data (n = 218) Analised (n = 218)

Fig. 1. Trial profile.

318

Feldens et al.

Page 3: Advising mothers about breastfeeding and weaning reduced pacifier use in the first year of life: a randomized trial

The intervention group received home visits for

advising the mother about healthy dietary prac-

tices within 10 days of the child’s birth, monthly

up to 6 months, and at 8, 10, and 12 months. The

dietary advice was given by 12 trained interven-

tion field workers who counseled the mothers

about breastfeeding and healthy weaning, based

on WHO recommendations known as the ‘Ten

Steps for Healthy Feeding Children Younger than

Two Years’ (21). The advice was provided in an

informal manner with consideration for the

mother’s opinions and concerns, as well as the

cultural and economic aspects of feeding practices

in Southern Brazil. Particularly, the dietary advice

aimed at exclusive breastfeeding up to 6 months.

Exclusive breastfeeding was defined as the infant

receiving only breast milk, without water, breast

milk substitutes, other liquids and solid foods,

except vitamins, minerals or medicine (25). The

mothers of breastfed babies who were older than

6 months were encouraged to continue breast-

feeding but they should gradually substitute three

breastfeeding meals by a three-times-a-day solid

diet so as to meet the requirement of family meals

at the age of 1 year. The mothers of the bottle-fed

babies who were older than 6 months were

encouraged to gradually substitute all bottles by a

five-a-day solid diet rich in nutrients, maintaining

reasonable intervals between meals. All mothers

were advised not to use bottle or breastfeeding as

pacifiers and they were encouraged to gradually

restrict either bottle or breastfeeding during the

night. The mothers were also advised against the

addition of sugars (sugarcane, honey) in fruits,

porridge, juices, milk, or other liquids and against

the provision of soft drinks, sweets, and savory

snacks; they were encouraged to avoid fried food

and to use salt in moderation. A leaflet was used

to guide the advice and was handed to the

mother as a reminder. No specific advice regard-

ing pacifier use was given. Our main hypothesis

is that home visits for dietary advice are expected

to promote exclusive breastfeeding up to

6 months and healthy weaning practices that

potentially contribute to reduce pacifier use in the

first year of life.

The intervention field workers were previously

trained on the 10 steps for healthy feeding of

infants and counseling skills. They received 8 h of

theoretical training and 8 h of practical training

based on a detailed adviser guide prepared for the

study; they were calibrated against the advice pro-

vided by a pediatric nutritionist (M.R.V.). During

the field work, they were systematically supervised

by this nutritionist on a weekly basis.

Research assessment questionnairesTrained interview field workers (n = 16) conducted

the research assessment by face-to-face interviews

with mothers from the intervention and control

groups. Quality control measures included a 12-h

training program (using standardized data collec-

tion forms and detailed interviewer guide) and

blinding of interviewers to the group status of the

mother–child pair. Anthropometric variables

(weight and length at birth) were collected at birth.

Social and demographic variables (child gender

and birth order, mother’s age and education at the

child’s birth, mother’s occupation status, family

income per capita, number of people living at

home, and family structure) were investigated at

the 6-month assessment. Number of people living

at home included children; family structure was

considered either nuclear (child living with mother

and father) or non-nuclear (child not living with

both parents). Dietary behavior variables were

assessed at the 6- and 12-month assessments, using

structured interviews of the beginning, duration,

and frequency of the feeding practices during the

previous 6 months. The research questionnaires

were tested in a pilot study of 16 mothers of chil-

dren aged 6 and 12 months attending primary care

services and modified accordingly.

At 12-months’ evaluation, depressive symptoms

were assessed using Beck Depression Inventory

(BDI) (26). Only a subsample of mothers was inves-

tigated due to financial costs. BDI is a self-assess-

ment depression measure. It was not designed to

generate a diagnosis, but to screen depressive

symptoms in nondiagnosed populations or to iden-

tify the intensity of diagnosed depressive episodes.

The intensity of depressive symptoms is classified

according to the score obtained: 0–11 minimal

depression, 12–19 mild depression, 20–35 moderate

depression, and 36–63 severe depression. BDI

assesses depressive symptoms in the previous

2 weeks. This instrument is easy to apply, and it

was translated and validated for Portuguese (27).

In this study, the final score was categorized as

minimum to mild (<19) and moderate to severe

(� 19).

Pacifier use assessmentThe 6- and 12-months’ interviews investigated,

separately for each month, the use of a pacifier. For

this purpose, parents were asked to answer the

319

Advising mother on breastfeeding reduces pacifier use

Page 4: Advising mothers about breastfeeding and weaning reduced pacifier use in the first year of life: a randomized trial

following questions: whether or not the child had

been used the pacifiers and if yes, the age of start-

ing and the age of stopping its use. The primary

outcome of this study—pacifier use in the first year

of life—was defined if the child had used a pacifier,

regarding the frequency, and duration of this

behavior.

Data analysisData analysis was carried out using the Statistical

Package for Social Science (SPSS, version 16.0, SPSS

Inc., Chicago, IL, USA). Participants were analyzed

according to their original group assignment. The

effect of the intervention on the use of a pacifier

was evaluated in contingency tables with chi-

square statistics, the effect size being reported

using relative risk (RR) with 95% confidence inter-

val (CI). Unadjusted and adjusted relative risks of

using pacifier during the first year were estimated

in Poisson regression with robust variance. First,

the relative risks and 95% confidence intervals

(95% CI) of each variable were estimated sepa-

rately. Later, multivariable analysis followed a

hierarchical approach to determine the risk factors

of pacifier use. We followed the criteria suggested

by Victora et al. (28). This model has been largely

applied in studying different child’s health out-

comes. In this study, we assumed that pacifier use

is associated with other early events in the child’s

life (29). Therefore, the variables were grouped in

four levels that represent distal, medial, and proxi-

mal determinants of pacifier use: socioeconomic

factors are the distal determinants influencing,

directly or indirectly, all other groups of risk fac-

tors. The second level included the immediate

social environment of the child and maternal

health, which may affect anthropometric variables.

These variables, in turn, affect behavior variables,

including presence of smoking into the house and

breastfeeding interruption in the first month of life.

Finally, all these above factors may affect child’s

pacifier use. We performed multivariable modeling

starting with all available risk factors in each level

using backward elimination if Wald P-value was

higher than 0.20, except for the variable that repre-

sent the intervention, which remained in the mod-

els irrespective of the statistical significance.

Selected variables at each level were included in

the final model. Therefore, the final model esti-

mates relative risks of the selected variables after

adjusting for (i) the variables of the same level or

upper selected in the final model; (ii) child’s group.

The interaction between mother’s depression and

breastfeeding interruption was also explored for

the outcome of interest. A two-tailed P-value of

less than 0.05 was used for a result to be considered

statistically significant.

Comparisons between children who were lost in

the follow-up and those who remained in the trial

regarding baseline variables (weight and length at

birth, maternal level of education and family

income) were also performed using t-tests for inde-

pendent samples.

Ethical aspectsThis study was approved by the Ethical Committee

of Universidade Federal do Rio Grande do Sul.

Parents gave a written informed consent for the

various research procedures. Both groups received

routine assistance by their pediatricians. Children

with anemia, overweight, wasting, stunting, or

developmental problems were referred to their pri-

mary care doctors for further assessment and treat-

ment.

Results

Among the 500 children whose mothers agreed to

participate in the trial, 397 received the 12-month

research assessment, and pacifier use data were

available for 375 of them: 78.5% (n = 157/200) of the

intervention group and 72.7% (n = 218/300) of the

controls initially recruited. Missing data (n = 22)

refer to children whose mothers did not know if the

child had actually used a pacifier. Over half of the

final sample were boys (58.7%; 220/375) and the

mother’s second-born child or greater (63.8%; 238/

373). The mother’s education varied largely from 0

to 13 years of schooling (mean 6.8, SD 2.7, median

6.0); 90.0% (325/361) of the fathers and 35.0% (129/

368) of the mothers had a paid occupation; the fam-

ily status was nuclear in 71.9% (266/370), and non-

nuclear in 28.5% (112/393) (Table 1).

There was no evidence of imbalance between the

intervention and the control groups in the distribu-

tion of family income, maternal education, and age

at the child’s birth, with the baseline variables

hypothesized as possible predictors of pacifier use

in infancy. The income was low for most of the

families, with 10.6% (16/151) of the families of the

intervention group and 11.4% (24/211) of the con-

trols living on a monthly income below 1 Brazilian

Minimum Wage (BMW), which nearly corre-

sponded to 80.00 US dollars/month during the

period of data gathering. In the intervention group,

320

Feldens et al.

Page 5: Advising mothers about breastfeeding and weaning reduced pacifier use in the first year of life: a randomized trial

10.3% (16/155), of the mothers had <4 years of

schooling, 61.3% (95/155) had 5–8 years, and

28.4% (44/155) nine and more; similarly these pro-

portions were 9.2% (20/217), 63.6% (138/217), and

27.2% (29/217) for the control group. The mother

was a teenager at the child’s birth for 16.7% (26/

156) of the intervention group and 18.9% (41/217)

of the controls. The proportion of losses to follow-

up as well as the reasons for such losses was simi-

lar between groups. In the intervention group,

these were the following: address not found

(3/200), refusal (12/200), family moved to another

city (19/200), infant given for adoption (1/200),

child death (1/200), and severe illness of the

mother (1/200). In the control group, these were

the following: address not found (28/300), refusal

(10/300), family moved to another city (24/300),

genetic illness in the child (2/300), child death

(1/300), and maternal death (1/300).

About 62% of all the children (231/375) have

used the pacifier in the first year of life, with a quar-

ter of the sample (94/375) starting its use before the

first month of life (Table 2). After that, the preva-

lence increased to 52% for 1-month-old children.

From the second month to the first year of life, the

prevalence of pacifier use had stabilized in 50%

and 53%, with a few children starting pacifier use

after 2 month and a few children stopping its use

in each subsequent month. Approximately half of

the children (50.1%) whose mothers reported using

the pacifier persisted with its use after 1 year.

There was evidence of difference in pacifier use

between the intervention and control groups

(Table 3). The proportion of children who have

used the pacifier was 55.4% (87/157) among the

intervention group and 66.1% (144/218) among the

Table 1. Sociodemographic, anthropometric and behav-ioral characteristics of the sampled children

Variables N (%)

Variables related to childSexBoys 220 (58.7)Girls 155 (41.3)Length at birth<49 cm 175 (47.8)�49 cm 191 (52.2)Weight at birth<2800 g 37 (10.1)�2800 g 329 (89.9)Single childYes 135 (36.2)No 238 (63.8)Breastfeeding interruption in the 1st month of lifeYes 46 (12.4)No 326 (87.6)Variables related to mothers/familyMother’s schooling<4 years 36 (9.7)4–8 years 233 (62.6)

>8 years 103 (27.7)Teenager motherNo 306 (82.0)Yes 67 (18.0)Mother’s occupationEmployed 129 (35.0)Home occupation 228 (62.0)Unemployed 11 (3.0)Mother’s level of depressionMinimal to mild 205 (82.3)Moderate to severe 44 (17.7)Family income<0.5 BMWa 120 (33.1)0.5 a 1.0 BMW 169 (46.7)

> 1.0 BMW 73 (20.2)Family structureNuclear 266 (71.9)Non-nuclear 104 (28.1)Number of people living at homeUp to 3 persons 94 (25.3)4 to 5 persons 200 (53.9)More than 5 persons 77 (20.8)Presence of smoker into the houseYes 150 (40.4)No 221 (59.6)

aBrazilian minimum wage.

Table 2. Characteristics of the study sample accordingto the use of pacifier within the first year of life. S~ao Leo-poldo-RS, Brazil

AgeStartedusing

Stoppedusing

Prevalenceof use

n/N %

<1-month-old 94 0 94/375 25.11-month-old 103 2 195/375 52.02-months-old 8 5 198/375 52.83-months-old 4 3 199/375 53.14-months-old 6 6 199/375 53.15-months-old 4 4 199/375 53.16-months-old 6 5 200/375 53.37-months-old 2 2 200/375 53.38-months-old 0 3 197/375 52.59-months-old 0 0 197/375 52.510-months-old 0 4 193/375 51.511-months-old 3 2 194/375 51.712-months-old 1 7 188/375 50.10–12-months-old 231 231/375 61.6

Table 3. Effect of intervention on the use of pacifier inthe first year of life

Group N

Pacifier usea

Pn (%) RR (95% CI)

Intervention 157 87 (55.4) 0.84 (0.71–0.99) 0.037Control 218 144 (66.1) 1.00

aPacifier use in the first year of life.

321

Advising mother on breastfeeding reduces pacifier use

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controls. The risk of using a pacifier was 16% lower

for the intervention group compared to the con-

trols (RR = 0.84; 95% CI = 0.71–0.99).Unadjusted analyses demonstrated that the vari-

ables mother’s level of depression, presence of a

smoker in the house, and having breastfeeding

interrupted in the first month of life were signifi-

cantly associated with the outcome (Table 4). Prev-

alence of pacifier use was not associated with the

others sociodemographic and socioeconomic vari-

ables, as well as with the family structure, number

of people living at home, birth order, age of the

mother, and anthropometric variables.

After the adjustments, the only variables that

remained associated with the outcome were

mother’s level of depression and breastfeeding

interruption in the first month of life: children

whose mothers had moderate or high level of

depression were 40% more likely to have used the

pacifier than their counterparts (RR = 1.40; 95% CI,

1.17–1.66). Moreover, those who were breastfed for

less than 1-month old had an increased risk of hav-

ing used the pacifier in the first year of life

(RR = 1.43; 95% CI: 1.20–1.69).One additional analysis was carried out to inves-

tigate if the exclusion of the variable ‘mother’s

level of depression’ would modify estimations of

the other variables. Breastfeeding interruption

remained strongly associated with the outcome

(RR = 1.52; 95% CI 1.33–1.74; P < 0.001), demon-

strating that the effect of this variable is not

affected by mother’s depression. Notwithstanding,

retaining this variable resulted in a better fit of the

model (log likelihood-ratio test). We also noted

that the interaction between mother’s depression

and breastfeeding interruption was not significant.

An additional analysis showed that including this

variable did not improve the model fit.

No difference was found between the children

who were lost in the follow-up and those who

remained at the 12-months’ assessment regarding

potential risk factors for childhood outcomes:

weight at birth (P = 0.283), length at birth

(P = 0.995), maternal level of education

(P = 0.158), and family income (P = 0.373).

Discussion

The results of this randomized trial demonstrated

that a nutrition program based on counseling of

mothers during the first year of their child’s life

significantly reduced pacifier use. A moderate

treatment effect was achieved, being difficult to

determinate the long-standing benefits of the inter-

vention. However, it has been demonstrated that

moderate treatment effect is more plausible to

occur in the population, and it is generally unreal-

istic to hope for large treatment effects in multifac-

torial outcomes (30, 31).

Pacifier use is associated with speech disorders

(10), allergies, intestinal parasitic diseases (32),

acute otitis media (11), and other infections (12).

Furthermore, pacifiers have a negative dentition

development, such as open bite, increased overjet,

posterior cross-bite (2–9, 24), and severe dental

injury (33). Therefore, preventing its use could con-

tribute to reducing these harmful outcomes. .

The lower frequency of pacifier use in the inter-

vention group may be explained, at least in part, by

longer breastfeeding duration, a practice which is

inversely associated with pacifier use (19). Few

studies have been conducted assessing the effect of

educational strategies on pacifier use (15). Neverthe-

less, pacifiers have been widely used even among

populations, which have been advised against their

negative interference on breastfeeding (34). This can

be explained due the fact that the use of pacifiers is

a deep-rooted habit, which has been associated with

some social and cultural aspects of the communities,

with a marked influence by social peers (34). Never-

theless, exposures to artificial nipples, such as paci-

fier, is common both in the hospital and during the

early months of life when nonnutritive sucking is

useful in helping to calm infants (35).

The prevalence of pacifier use in the control

group during the first year of life (66.1%) was

higher than that which was observed for children

living in the Brazilian state capitals (42.6%), but

similar to that found in Porto Alegre, an important

urban center near S~ao Leopoldo (1). Previous stud-

ies in Asia and Oceania found a prevalence that is

below to 20%, while in the majority of the countries

at least half of the children had used a pacifier in

the first year of life (36). In this study, the preva-

lence increased in the first month of life and stabi-

lized thereafter. This is in accordance with a

previous study (13) and demonstrates that

mother’s counseling regarding the use of pacifiers

should be done preferably during pregnancy.

Therefore, it is possible that the prevention cam-

paigns, when implemented after the first months

of life, would fail since a low rate of children start

pacifier use after this age.

A strong association could be seen between

the use of pacifiers and the mother’s level of

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depression. To our knowledge, it is the first study

to assess such an association. Although we did not

establish the onset of depressive symptomatology

in our study, it is important to emphasize that

depressive symptoms that were detected

12 months after birth may not represent a mental

Table 4. Unadjusted and Adjusted assessment of socioeconomic, demographics, behavioral and anthropometrics vari-ables associating with the use of pacifier in the first year of life (Poisson regression analysis)

Variables NaUse of pacifier

Unadjusted

P

Adjusted

Pn (%) RR (95% CI) RR (95% CI)

Demographics and socioeconomic characteristicsSexBoys 220 130 (59.1) 1.00 0.229 #Girls 155 101 (65.2) 1.10 (0.94–1.29)Mother’s schooling<4 years 36 21 (58.3) 0.98 (0.72–1.35) 0.643 #4–8 years 233 149 (63.9) 1.08 (0.90–1.30)

> 8 years 103 61 (59.2) 1.00Family income<0.5 BMWb 120 70 (58.3) 1.00 0.693 #0.5 a 1.0 BMW 169 104 (61.5) 1.06 (0.87–1.28)

>1.0 BMW 73 47 (64.4) 1.10 (0.88–1.39)Mother’s occupationEmployed 129 80 (62.0) 1.00 0.984 #Home occupation 228 140 (61.4) 0.99 (0.84–1.17)Unemployed 11 7 (63.6) 1.03 (0.64–1.64)Immediate social environment of the child and maternal healthFamily structureNuclear 266 165 (62.0) 1.04 (0.87–1.25) 0.672 #Non-nuclear 104 62 (59.6) 1.00Number of people living at homeUp to 3 persons 94 61 (64.9) 1.00 0.374 #4 to 5 persons 200 117 (58.5) 0.90 (0.75–1.09)More than 5 persons 77 51 (66.2) 1.02 (0.82–1.27)Single childYes 135 88 (65.2) 1.08 (0.92–1.27) 0.321 #No 238 143 (60.1) 1.00Teenager motherNo 306 193 (63.1) 1.11 (0.89–1.39) 0.357 #Yes 67 38 (56.7) 1.00Mother’s level of depressionMinimal to mild 205 122 (59.5) 1.00 <0.001 1.00 0.001Moderate to severe 44 37 (84.1) 1.41 (1.19–1.68) 1.40 (1.17–1.66)Anthropometric variablesLength at birth<49 cm 175 114 (65.1) 1.11 (0.95–1.30) 0.200 1.15 (0.96–1.39) 0.129�49 cm 191 112 (58.6) 1.00 1.00Weight at birth<2800 g 37 23 (62.2) 1.01 (0.77–1.31) 0.956 #�2800 g 329 203 (61.7) 1.00Behavioral variablesPresence of smoker into the houseYes 150 102 (68.0) 1.18 (1.01–1.39) 0.037 1.06 0.554No 221 127 (57.5) 1.00 1.00 (0.88–1.27)Breastfeeding interruption in the 1st month of lifeYes 46 41 (89.1) 1.54 (1.34–1.76) <0.001 1.43 (1.20–1.69) <0.001No 326 189 (58.0) 1.00 1.00

aThe total number of participants was smaller than the effective sample at the 1 year assessment (n = 375) due tomissing information in the following variables: mother’s schooling and breastfeeding interruption in the 1st month oflife: n = 3; family income: n = 13; mother’s occupation: n = 7; family structure: n = 5; number of people living at homeand presence of smoker into the house: n = 4; single son and teenager mother: n = 2; length and weight at birth: n = 9;mother’s level of depression was collected in a subsample of N = 249 (missing = 126).bBMW: Brazilian MinimumWage—nearly corresponded to 80.00 US dollars/month during the period of data gathering.#Non-significant - variable not included in the final model.

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illness directly related to postpartum but may

instead represent an underlying maternal pathol-

ogy that was not previously diagnosed. Neverthe-

less, possible confounding effect of level of

depression on smoke status suggests that the latter

is just a mediator for the association between level

of depression and use of a pacifier. This result

raises the hypothesis that the mother’s level of

depression can, in part, explain the association

found for other covariates with the outcome.

One could argue that final sample size consid-

ered in our final multivariable model may be a par-

ticular concern, especially due to the possibility of

selection bias when including the variable mother’s

level of depression (n = 249). However, the poorer

fit of the model observed when we omitted this

variable indicated that mother’s level of depression

should be taken into account when assessing pre-

dictors for pacifier’s use. Further studies should be

performed to assess the pathways for such associa-

tion during the child’s life course. Notwithstand-

ing, the results demonstrated that retaining the

variable mother’s level of depression did not

impact the association between short breastfeeding

duration and use of pacifier.

Breastfeeding interruption before 1 month of life

was a risk factor for the use of pacifiers, as has been

described in previous studies (13, 37). One may

argue that the relation could be considered in the

inverse direction, as those who had used pacifiers

could be at a greater risk of early discontinuation of

breastfeeding. In such scenario, pacifier use may

have been the cause or a mere strategy used by the

mother to stop breastfeeding. In this study, the vari-

ables, ‘age of starting the use of pacifier’ and ‘age of

breastfeeding interruption’ were obtained from

each one of the first 12 months of age. This strategy

allowed the use of the variable breastfeeding inter-

ruption before 1 month, reducing the possibility of

reverse causality bias. This is in accordance with a

previous study (13) and suggests that the pacifier

could be considered as a possible compensatory

factor for breastfeeding interruption.

Previous studies demonstrated the influence of

gender, low birth weight, smoking status, and age

of the mother, as well as the lower socioeconomic

status on the prevalence of pacifier use (3, 12, 13,

16, 34, 35, 38, 39). However, in this study, none of

these covariates were associated with the outcome.

It is possible that such differences could be

explained, at least in part, by variations in popula-

tions under study and on how cultural traits could

have influenced the results of published studies.

Particularly, the relative homogeneity in socioeco-

nomic classification across our sample could have

an impact on the lack of association between socio-

economic indicators and prevalence of pacifiers.

Analogous observation was found in a previous

study (34). Furthermore, the fact that smoking sta-

tus has lost significance after being adjusted for

level of depression indicates that the association

reported in previous studies between smoking and

use of pacifiers may have some influence on possi-

ble confounders.

This study brings relevant information for the

public health perspective and for the scientific

community. For instance, our results indicate that

oral health promotion programs should integrate

preventives strategies based on the common risk

approach rather than focusing only on a single

problem. Therefore, preventive advice on pacifier

use should be integrated into a broad approach

aimed at promoting breastfeeding and other risk

factors that are common for a widely range of

childhood disease (40).

Some aspects of the methodology of this investi-

gation merit discussion. The fairly high proportion

of losses is a common problem in cohort studies,

mainly in populations with high mobility.

Although identification data were extensively col-

lected by researchers at the beginning of the study

to reduce this problem, a significant number of

families moved away within the first few weeks

after the child’s birth without letting the research

staff know about it or refused to participate in the

study. However, selection bias is unlikely to be a

major problem, considering the similarity in base-

line characteristics between those lost and those

not lost. The possibility of recall bias has to be con-

sidered, since the investigators had to rely on the

memory of the participants. However, the effect of

this bias is not expected to be significant, since the

period between pacifier use and the interview was

never longer than 6 months. Furthermore, the

effects of variables are more likely to be attenuated

than increased by this phenomenon (41).

In conclusion, this study demonstrated the effec-

tiveness of home visits for advising mothers about

breastfeeding and weaning on the reduction of

pacifier use in the first year of life. Early use of pac-

ifiers in the first month of life, as was observed in

this study, demonstrated that the mother’s coun-

seling regarding the use of pacifier should be done

during pregnancy. This study also found that the

mother’s level of depression and breastfeeding

interruption in the first month of life are associated

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with the use of pacifiers and this could be con-

firmed in further studies with different popula-

tions. Taken together, these findings suggest the

need for public health strategies that address early

advice on pacifier use to promote child oral and

general health.

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