A Phase 4 interventional study of Beta carotene and Vitamin D3 in Hyaline Membrane Disease and Necrotizing Enterocolitis of Newborn, sponsored by Indonesia University. Status unknown at 1 site in Indonesia. Open to female participants aged 17 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-13.
Sponsored by Indonesia University · Phase 4, Interventional, and Prevention
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.
This study is a randomized controlled trial and held in Cipto Mangunkusumo Hospital.
Pregnant women 28-34 weeks of gestational age, who fulfill the inclusion criteria, divide into two groups. Subjects from both groups receive the hospital protocol of preterm birth, 4 doses of 6 mg of dexamethasone, intravenous 12 hours apart to support lung maturation. Subjects in intervention group receive oral single-dose beta-carotene 25,000 IU, oral single-dose vitamin D3 50,000 IU and oral zinc 50 mg/day for 3 days. The maternal dan cord blood sample are obtained for zinc, vitamin A and 25(OH)D levels before and after intervention. After the premature neonates was born, observation will be done for maximum period of 4 weeks. The presence and severity of HMD and feeding intolerance or NEC will be recorded. Neonates showing any signs of HMD and/or abdominal distension will need to undergo additional chest/abdominal x-ray procedures.
25 studies on the registry are indexed under Hyaline Membrane Disease; 10 are open to participants now.
This study's planned enrollment of 120 is below the median of 160 across 14 interventional studies indexed under Hyaline Membrane Disease.
Browse Hyaline Membrane Disease studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
* beta carotene 25,000 IU * vitamin D3 50,000 IU * zinc 50 mg * dexamethasone 6 mg
Dietary Supplement: Beta carotene · Dietary Supplement: Vitamin D3 · Dietary Supplement: Zinc · Drug: Dexamethasone
dexamethasone 6 mg
Drug: Dexamethasone
Beta carotene 25,000 IU
Vitamin D3 50,000 IU
Also known as: Cholecalciferol
Zinc 50 mg
Also known as: Zinc picolinate
Dexamethasone 6 mg
Hyaline membrane disease
The presence and severity of RDS (HMD) will be noted, according to chest X-ray result
Time frame: 1,5 years
Feeding Intolerance
The presence and severity of necrotican enterocolitis will be noted, according to abdominal x-ray result
Time frame: 1,5 years
Plan to share: Undecided — The research findings will be disseminated via publication of results
No publications or documents are linked to this record.
Started Jan 2017 (actual). Primary completion is estimated for Dec 2018, 23 months after the start.
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This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cholecalciferol · Zinc