Enteral vitamin A for reducing severity of bronchopulmonary dysplasia in extremely preterm infants: a randomised controlled trial

BMC Pediatrics

Study Protocol

Karen Simmer¹  Sanjay Patole¹  J. Jane Pillow²  Abhijeet Rakshasbhuvankar² 

[1] King Edward Memorial Hospital, 374 Bagot Road, 6008, Subiaco, WA, Australia;Centre for Neonatal Research and Education, Division of Paediatrics and Child Health (M561), Medical School, University of Western Australia, 6009, Crawley, WA, Australia;King Edward Memorial Hospital, 374 Bagot Road, 6008, Subiaco, WA, Australia;Centre for Neonatal Research and Education, Division of Paediatrics and Child Health (M561), Medical School, University of Western Australia, 6009, Crawley, WA, Australia;School of Human Sciences (M309), University of Western Australia, 6009, Crawley, WA, Australia;

关键词: Bronchopulmonary dysplasia;    Chronic lung disease;    Vitamin A;    Preterm infant;    Randomized controlled trial;   

DOI  :  10.1186/s12887-017-0958-x

 received in 2016-09-16, accepted in 2017-12-07,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundIntramuscular vitamin A supplementation decreases the risk of bronchopulmonary dysplasia (BPD) in very-low-birth-weight preterm infants without significant adverse effects. However, intramuscular vitamin A supplementation is not widely accepted because of the discomfort and risk of trauma associated with repeated injections. Enteral vitamin A supplementation has not been studied adequately in the clinical trials. Enterally administered water-soluble vitamin A is absorbed better than the fat-soluble form. We hypothesised that enteral administration of a water-soluble vitamin A preparation will decrease severity of BPD compared with a control group receiving placebo.MethodsWe plan a double-blind randomised placebo-controlled trial at a tertiary neonatal-perinatal intensive care unit. Eligibility criteria include infants born at less than 28 weeks’ gestational age and less than 72 h of life. Infants with major congenital gastrointestinal or respiratory tract abnormalities will be excluded. After parental consent, infants will be randomized to receive either enteral water-soluble vitamin A (5000 IU once a day) or placebo. The intervention will be started within 24 h of introduction of feeds and continued until 34 weeks’ post-menstrual age (PMA).The primary outcome is severity of BPD at 36 weeks’ PMA. Severity of BPD will be assessed objectively from the right-shift of the peripheral oxyhaemoglobin saturation versus partial pressure of inspired oxygen (SpO2-PiO2) curve. We require 188 infants for 80% power and 5% significance level based on an expected 20% decrease in the right shift of the SpO2-PiO2 curve in the vitamin A group (primary outcome) compared with control group at 36 weeks’ PMA, and a 20% attrition rate.Secondary outcomes will be plasma and salivary concentrations of vitamin A on day 28 of the trial (first 30 infants), lung and diaphragm function, clinical outcomes at 36 week’ PMA or before discharge/death, and safety of vitamin A.DiscussionBPD poses a significant economic burden on the health-care system. If our study shows that enteral supplementation of water-soluble vitamin A is safe and effective for decreasing the severity of BPD, it will provide the opportunity to further evaluate a simple, globally acceptable preventive therapy for BPD.Trial registrationANZCTR; ACTRN12616000408482 (30th March 2016).

【 授权许可】

CC BY   
© The Author(s). 2017