Protocol for assessing if behavioural functioning of infants born
Kei Lui,
Peter J Anderson,
Peter G Davis,
Jeanie L Y Cheong,
Gillian Opie,
Srinivas Bolisetty,
Karen Simmer,
Jacqueline Stack,
Helen Liley,
Kenneth Tan,
Lex William Doyle,
Maria Makrides,
Mary Sharp,
Carmel T Collins,
Karen P Best,
Jacqueline F Gould,
Thomas R Sullivan,
Robert A Gibson,
Andrew J McPhee,
Javeed Travadi,
Rachel M Roberts,
Scott Morris
Affiliations
Kei Lui
12 Department of Newborn Care, Australian and New Zealand Neonatal Network, Royal Hospital for Women, National Perinatal Epidemiology and Statistic Unit, University of New South Wales, Sydney, New South Wales, Australia
Peter J Anderson
5 Monash Institute of Cognitive and Clinical Neuroscience, Monash University, Clayton, Victoria, Australia
Peter G Davis
1 Newborn Research Centre, The Royal Women`s Hospital, Melbourne, Victoria, Australia
Jeanie L Y Cheong
Newborn Research, Royal Women`s Hospital, Parkville, Victoria, Australia
Gillian Opie
Department of Obstetrics & Gynaecology, University of Melbourne, Melbourne, Victoria, Australia
Srinivas Bolisetty
Division of Newborn Services, Royal Hospital for Women, Randwick, New South Wales, Australia
Karen Simmer
Medical School, The University of Western Australia, Perth, Western Australia, Australia
Jacqueline Stack
School of Women’s and Children’s Health, University of New South Wales, Sydney, New South Wales, Australia
Helen Liley
Mater Research Institute The University of Queensland, South Brisbane, Queensland, Australia
Kenneth Tan
Monah Newborn, Monash Children’s Hospital, Clayton, Victoria, Australia
Lex William Doyle
Clinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, Australia
Maria Makrides
SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia
Mary Sharp
2 School of Medicine, The University of Western Australia, Perth, Western Australia, Australia
Carmel T Collins
Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia
Karen P Best
Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia
Jacqueline F Gould
SAHMRI Women and Kids, South Australian Health and Medical Research Institute, North Adelaide, South Australia, Australia
Thomas R Sullivan
South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia
Robert A Gibson
SAHMRI Women and Kids, South Australian Health and Medical Research Institute, North Adelaide, South Australia, Australia
Andrew J McPhee
SAHMRI Women and Kids, South Australian Health and Medical Research Institute, North Adelaide, South Australia, Australia
Javeed Travadi
Department of Paediatrics, Royal Darwin Hospital, Casuarina, Northern Territory, Australia
Rachel M Roberts
School of Psychology, The University of Adelaide, Adelaide, South Australia, Australia
Scott Morris
College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
Introduction During the last trimester of pregnancy, the fetal brain undergoes a rapid growth spurt and accumulates essential nutrients including docosahexaenoic acid (DHA). This takes place ex-utero for infants born <29 weeks’ gestation, without the in-utero provisions of DHA. Infants born <29 weeks’ are more likely to experience behavioural and emotional difficulties than their term-born counterparts. It has been hypothesised that supplementing preterm infants with dietary DHA may alleviate insufficiency and subsequently prevent or minimise behavioural problems. This protocol describes a follow-up of infants born <29 weeks gestation who were enrolled in a randomised controlled trial (RCT) of DHA supplementation. We aim to determine whether DHA supplementation improves the behaviour, and general health of these infants.Methods and analysis Infants born <29 weeks’ gestation were enrolled in a multicentre blinded RCT of enteral DHA supplementation. Infants were randomised to receive an enteral emulsion that provided 60 mg/kg/day of DHA or a control emulsion commenced within the first 3 days of enteral feeding, until 36 weeks’ postmenstrual age or discharge home, whichever occurred first. Families of surviving children (excluding those who withdrew from the study) from the Australian sites (up to 955) will be invited to complete a survey. The survey will include questions regarding child behavioural and emotional functioning, executive functioning, respiratory health and general health. We hypothesise that the DHA intervention will have a benefit on the primary outcome, parent-rated behaviour and emotional status as measured using the Total Difficulties score of the Strengths and Difficulties Questionnaire. Detecting a 2-point difference between groups (small effect size of 0.25 SD) with 90% power will require follow-up of 676 participants.Ethics and dissemination The Women’s and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/16/WCHN/184). Results will be disseminated in peer-reviewed publications and conference presentations.Trial registration number ACTRN12612000503820.
