Mediators in Preterm Infants With Late-onset Sepsis: A Randomized Controlled Trial
- PMID: 30896608
- DOI: 10.1097/MPG.0000000000002238
Mediators in Preterm Infants With Late-onset Sepsis: A Randomized Controlled Trial
Erratum in
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Mediators in Preterm Infants With Late-onset Sepsis: A Randomized Controlled Trial: Erratum.J Pediatr Gastroenterol Nutr. 2023 Nov 1;77(5):e74. doi: 10.1097/MPG.0000000000003921. Epub 2023 Oct 27. J Pediatr Gastroenterol Nutr. 2023. PMID: 37889620 Clinical Trial. No abstract available.
Abstract
Objective: To evaluate biochemical and clinical effects of 2 different doses of vitamin D supplementation in preterm infants with late-onset sepsis (LOS).
Study design: A double blinded randomized controlled stratified trial included preterm infants with gestational age (GA) ≥28 weeks with LOS. Subjects were randomly assigned to receive 400 or 800 IU/day of vitamin D3. Serum concentrations of 25(OH)D, TNF-α, and IL-6 were measured at enrollment, 7 days after vitamin D supplementation, and at 40 weeks of postmenstrual age (PMA). Short-term outcomes and growth parameters were assessed.
Results: A total of 50 infants were enrolled, 25 in each group. Seventy-six percentage of enrolled infants were vitamin D-deficient at enrollment in both groups whereas only one infant in the 400 IU and none in the 800 IU group remained deficient at 40 week's PMA; vitamin D concentrations at 40 weeks PMA were 54.8 ± 35.1 and 67.4 ± 37.1 ng/mL, respectively, P = 0.01). None of the infants enrolled in the study had signs of vitamin D toxicity. Serum pro-inflammatory cytokines IL-6 and TNF- α concentrations decreased at 1 week and at discharge in both groups without differences between groups. The 2 groups did not differ in anthropometric measurements, duration of oxygen and respiratory support, duration of antimicrobial use, length of hospital stay, and mortality.
Conclusions: A dose of 400 IU of vitamin D was adequate to treat vitamin D deficiency in the majority of premature infants with LOS. The 2 dosing regimens did not differ in clinical or biochemical changes.
Trial registration: ClinicalTrials.gov NCT02273843.
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