ProVIDe Study Newsletter No. 4 August 2016

This ProVIDe Study newsletter is a regular update for the ProVIDe team, hospital staff and the LiFePATH group so that everyone can stay in touch with how recruitment and the study is progressing. Six NZ NICUs are now recruiting and we have randomised 196 babies. The target is 430 babies.

Christchurch Wellington

Middlemore

ProVIDe study babies recruited vs. target

Well done - recruitment is now over 45%

HREC approval for 3 Australian sites HREC (the Australian ethics committee) has given Ethics approval for the following sites:

Mater Health Services, Brisbane Royal Brisbane & Women’s Hospital Royal Women’s Hospital, Melbourne

We will begin training at the Mater shortly and plan to start recruiting in early September.

Although the “actual” line is starting to fall away from the target, we expect a boost to the recruitment rate later in the year because 3 Australian Hospitals will join the study and begin recruiting in late 2016.

Hello everyone! This is Safayet from Liggins Institute. I work as the Data Management Coordinator for the LifePath group. Professionally I am a computer engineer, graduated in 2000 and completed my Masters from UK in 2012. Although I have been working on database design and development for some years now, I started working on clinical data management from late 2006 when I joined Medical Research Council’s (MRC, UK) Gambian Unit. I joined Liggins in 2013 and am involved with the database design, development and management of clinical trials and cohort studies. So far ProVIDe is the biggest clinical trial on preterm babies. Management of trial bags of this study is challenging because of short shelf-life; however, this has been well managed by the study and data management team, which is fantastic! It is also exciting to learn that the study is moving to Australia. I am glad to be a part of the team. My best wishes to everyone involved in this study!

Target

Actual

Profile: ProVIDe Study Data Team - Safayet Hossin

Profile: ProVIDe Study Auckland City Hospital - Research Nurse: Sabine Huth

Hello from Auckland ! My name is Sabine Huth and I completed my nursing training in Austria many, many years ago. I have been working and studying (BA, Masters papers) in NZ since 1991 and after working in different areas final-ly found my niche in NICU! The care of the pre-term baby is extremely rewarding and I discov-ered my passion for Research in 2007 starting with the BOOST trial. Research is fundamental in order to find and provide the best care for the fragile preterm baby.

So I am proud to be research nurse for the great ProVIDe study and I am also involved in a few other trials and ANZNN data entry.

It would be great to meet all the other research teams around the country. Any ideas how we could arrange that ? Best of luck to everyone and we shall keep successfully “Providing”!

Important Please send all study documentation to the Liggins Institute in the prepaid courier packs provided and addressed to Grace McKnight .

Monthly Consort Reports can be emailed to Barbara at bcormack@adhb.govt.nz and don’t need to be posted or couriered.

For Consort Reports, please report your numbers based on the randomisation date of the participant, not the birthdate.

Red blood cell infusions do not need to be recorded on Form H 1 (Intravenous Fluids) as we do not count this as a nutritional fluid.

If there have been any changes to the composition of your intravenous fluids in the past 6 months please let Barbara know

Ethnicity—please record Fijian Indian, Chinese, and Indian Hindu as Asian (not other)

ProVIDe Study Recruitment to 13 July 2016

Profile: ProVIDe Study Data Team - Grace Mcknight

Hello, I am Grace Mcknight from Auckland. I am currently doing my BA in computing and sociology part time at the University of Auckland while working full time as a Research and Data Assistant at the Liggins Institute doing data entry and data clerking tasks for various studies. I enjoy all aspects of working within the research projects the LiFePATH involves from the beginning stages to watching the data come together at the end. I continue to learn amazing and interesting new things every day while working with an excellent team.

Working for the ProVIDe study has been very rewarding!! Due to the study helping take better care of very preterm and fragile babies so they can grow and develop into healthy children for the future.

Hope to see you all someday soon. You are all doing tremendous work in helping preterm babies develop.

Study Centre Date from Babies

Assessed

Babies

Randomised

Babies

Recruited

Auckland 29 Apr 2014 91 68 75% 55 60%

Christchurch 08 Aug 2014 24 19 79% 17 71%

Waikato 01 Jul 2014 72 42 58% 39 54%

Dunedin 18 Jul 2014 19 9 47% 9 47%

Middlemore 01 Aug 2014 49 35 71% 24 49%

Wellington 01 Aug 2014 96 39 41% 39 41%

Overall 29 Apr 2014 351 212 60% 183 52%

Some recent publications that may be of interest

1. Hay WW, Ziegler EE: Growth failure among preterm infants due to insufficient protein is not innocuous and must be prevented. J Perinatol 2016, 36(7):500-502.

2. Corpeleijn WE, de Waard M, Christmann V, van Goudoever JB, Jansen-van der Weide MC, Kooi EM, Koper JF, Kouwenhoven SM, Lafeber HN, Mank E et al: Effect of Donor Milk on Severe Infections and Mortality in Very Low-Birth-Weight Infants: The Early Nu-trition Study Randomized Clinical Trial. JAMA Pediatr 2016.

3. Cormack BE, Embleton ND, van Goudoever JB, Hay WW, Jr., Bloomfield FH: Comparing apples with apples: it is time for standardized reporting of neonatal nutrition and growth studies. Pediatr Res 2016, 79(6):810-820.

ProVIDe study 2 year follow up

The 2 year follow up will be beginning soon and we will be in touch shortly about this. Coila Bevan has be employed on a short term basis to liaise with each site on routine and other follow up visits as required for ProVIDe Study participants from early September.

A minimum dataset will be collected for all participants:

The following additional data will be collected where possible:

Anthropometry Waist circumference Mid arm circumference

Body composition (by bio-electrical impedance analysis using ImpediMed Imp SFB7 device) Total body fat mass Fat free mass

Questionnaires

ProVIDe Child and Family Home environment

Child Eating Behaviour Eating behaviour

BRIEF-P Everyday behavioural manifestations of executive function

Child Behaviour Checklist for Ages 11/2 to 5 years

Identifies behaviours/problems interfering with functioning

Assessment Tool

Bayley III

Cognitive development

Language development

Motor development

Paediatric examination

Paediatric assessment of neurodevelopmental disability Blindness Deafness Cerebral palsy - Gross motor function classification

Anthropometry (at the time of Bayley III and Paediatric assessment)

Weight Standing height Head circumference

Questionnaire (only if no Bayley and Paediatric Assessment)

Health Status Questionnaire by phone

For more information please contact Barbara Cormack, Tel 3074949 Ext 23351, Mobile 021 252 9469 Email: bcormack@adhb.govt.nz