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

Phase 4

• Conditions: Hyaline Membrane Disease; Necrotizing Enterocolitis of Newborn
• Interventions: Dietary Supplement: Beta carotene; Drug: Dexamethasone; Dietary Supplement: Vitamin D3; Dietary Supplement: Zinc

• Registration Number: NCT03366584
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2017-12-03
• Study First Posted: 2017-12-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

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Exclusion Criteria

• Multiple pregnancy
• Drug allergy
• Fetal congenital malformation
• Maternal gestational diabetes mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Vitamin D3	* beta carotene 25,000 IU * vitamin D3 50,000 IU * zinc 50 mg * dexamethasone 6 mg
Intervention	Beta carotene	* beta carotene 25,000 IU * vitamin D3 50,000 IU * zinc 50 mg * dexamethasone 6 mg
Intervention	Zinc	* beta carotene 25,000 IU * vitamin D3 50,000 IU * zinc 50 mg * dexamethasone 6 mg
Control	Dexamethasone	dexamethasone 6 mg
Intervention	Dexamethasone	* beta carotene 25,000 IU * vitamin D3 50,000 IU * zinc 50 mg * dexamethasone 6 mg

Primary Outcome Measures

Name	Time	Method
Hyaline membrane disease	1,5 years	The presence and severity of RDS (HMD) will be noted, according to chest X-ray result

Secondary Outcome Measures

Name	Time	Method
Feeding Intolerance	1,5 years	The presence and severity of necrotican enterocolitis will be noted, according to abdominal x-ray result

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia