The Effect of β-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key morbidities found in premature neonates which resulted in high mortality rate in Indonesia. Cochrane meta-analysis proved that antenatal steroid therapy can reduce the morbidity and mortality rate of premature neonates. But there is still different outcomes and severity of disease in preterm newborn receiving the same dose of antenatal steroid therapy. This raises questions whether there are other factors influencing the development and maturity of lung and gut in preterm newborn, aside from steroid therapy. Vitamin A, D and zinc are already known for their function in fetal lung and gut development. To our best of knowledge, no study has evaluated the effect of these vitamins levels on HMD and feeding intolerance in premature neonates. Therefore, the aim of this study want to evaluate the effect of antenatal steroid therapy versus co-administered β-carotene, vitamin D3, zinc and antenatal steroid therapy on the presence and severity of HMD and feeding intolerance in premature neonates.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indonesia University
• Treatments: BB 1101; Beta Carotene; Carotenoids; Cholecalciferol; Dexamethasone; Dexamethasone acetate; Ergocalciferols; Picolinic acid; Vitamin D; Vitamins; Zinc

Criteria

Inclusion Criteria:

• Pregnant women who has preterm birth in 28-34 weeks gestational age

Exclusion Criteria:

• Multiple pregnancy

• Drug allergy

• Fetal congenital malformation

• Maternal gestational diabetes mellitus