Vitamin C supplementation in very preterm infants: a randomised controlled trial
What this study found
No significant differences were seen in the primary clinical outcomes across the ascorbic acid regimens. Oxygen requirement at 28 days was 49, 34, and 38 for LL, LH, and HH, respectively (p = 0.28), and at 36 weeks PMA it was 36, 24, and 16 (p = 0.06), suggesting a non-significant trend toward better respiratory outcomes with higher vitamin C intake. Retinopathy of prematurity was also similar across groups: 30, 34, and 32 (p = 0.78). The authors reported no evidence of harmful pro-oxidant effects from higher ascorbic acid supplementation and considered providing at least this level of…
- Study & population
- Randomized controlled trial in very preterm or very low birth weight infants admitted to a neonatal intensive care unit within 48 hours of birth.
- Intervention
- Very preterm or very low birth weight infants were randomized to parenteral and/or oral ascorbic acid regimens for 28 days.
- Key limitation
- The trial was small and single-center, with only 119 infants and six deaths overall, limiting power to detect modest clinical effects.
Original abstract
Objective: To determine whether regulating vitamin C (ascorbic acid: AA) intake to achieve higher or lower plasma concentrations was associated with improved clinical outcome. Design: A double blind, randomised controlled trial. Setting: Neonatal intensive care unit at Christchurch Women’s Hospital. Patients: Infants with birth weight <1500 g or gestation <32 weeks, admitted to the unit within 48 hours of birth. Intervention: Infants were randomised to one of three protocols with regard to AA supplementation for the first 28 days of life: group LL received low supplementation throughout; group LH received low until day 10 and then high: group HH received high throughout. Main outcome measures: Primary outcome measures were oxygen requirement at 28 days and 36 weeks postmenstrual age, total days supplemental oxygen, and retinopathy of prematurity. AA concentrations were measured at study entry (day 2), and days 10, 21, and 28. Results: A total of 119 infants were enrolled over 24 months (mean gestation 28.4 weeks; birth weight 1161 g). Six infants died, and these had significantly higher AA concentrations before randomisation than surviving infants (116 μmol/l (95% confidence interval 90 to 142) v 51 μmol/l (45 to 58), p<0.0001). There were no significant differences in primary outcomes between the groups. However, the proportion of surviving infants with an oxygen requirement at 36 weeks postmenstrual age in group HH (19%) was half that in group LL (41%) (p = 0.06). Conclusions: In a randomised controlled trial, no significant benefits or harmful effects were associated with treatment allocation to higher or lower AA supplementation throughout the first 28 days of life.