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Eur J Pediatr. 2019 Aug;178(8):1255-1265. doi: 10.1007/s00431-019-03412-w. Epub 2019 Jun 17.

Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial.

Author information

1
Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drsriparnabasu@rediffmail.com.
2
Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, India. drsriparnabasu@rediffmail.com.
3
Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
4
Department of Biochemistry, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.

Abstract

This randomized double-blind placebo-controlled trial evaluated the effects of early postnatal oral vitamin A supplementation (VAS) in 196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24 h of age. Eligible infants were randomized to receive aqueous syrup of vitamin A (10,000 IU of retinol/dose; n = 98) or placebo (n = 98) on alternate days for 28 days. Primary outcome variable was composite incidence of all-cause mortality and/or oxygen requirement for 28 days. Secondary outcome variables were safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications. On intention-to-treat analysis, composite incidence of all-cause mortality and oxygen requirement for 28 days was significantly lower in vitamin A group (relative risk (95% confidence interval), 0.440 (0.229-0.844); p < 0.05, number needed to benefit, 7). Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay were also significantly lower in vitamin A group. Serum retinol concentration improved significantly after VAS. No major adverse effect was observed.Conclusions: Early postnatal oral VAS was associated with better composite outcome of all-cause mortality and oxygen requirement without any major adverse effects.Clinical Trial Registration: Clinical Trials Registry of India (CTRI/2017/03/008131). What is Known: • Postnatal intramuscular vitamin A supplementation improves the survival, respiratory outcome and other morbidities in very low birth weight neonates without major adverse effects. • Limited studies on oral vitamin A supplementation did not document substantial benefits. What is New: • Early postnatal alternate-day oral vitamin A supplementation at the dose of 10,000 IU/dose for 28 days improves the composite outcome of death and oxygen requirement in very low birth weight neonates with respiratory distress • No major adverse effects were documented.

KEYWORDS:

Neonate; Oral; Very low birth weight; Vitamin A supplementation

PMID:
31209560
DOI:
10.1007/s00431-019-03412-w
[Indexed for MEDLINE]

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