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

University of Indonesia (UI)

Status and phase: Unknown; Phase 4

Conditions: Hyaline Membrane Disease; Necrotizing Enterocolitis of Newborn

Treatments: Dietary Supplement: Vitamin D3; Dietary Supplement: Beta carotene; Dietary Supplement: Zinc; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03366584

190/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 17 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Intervention

Experimental group

Description:

* beta carotene 25,000 IU * vitamin D3 50,000 IU * zinc 50 mg * dexamethasone 6 mg

Treatment:

Drug: Dexamethasone

Dietary Supplement: Zinc

Dietary Supplement: Beta carotene

Dietary Supplement: Vitamin D3

Control

Active Comparator group

Description:

dexamethasone 6 mg

Treatment:

Drug: Dexamethasone