Clinical trial NCT03366584: The Effect of β-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
Official title: The Effect of Co-administered β-Carotene, Vitamin D3, Zinc and Antenatal Steroid Therapy on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyaline Membrane Disease
Necrotizing Enterocolitis of Newborn
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research will be held in Cipto Mangunkusumo General Hospital. Each participant of each group will be given dexamethasone 2x6 mg intravenous for 2 days which aims to support lung maturation followed by planned delivery within 1 week due to indication of maternal or fetal. The maternal dan cord blood sample are obtained for zinc, vitamin A and 25(OH)D levels examinations. Randomly, subjects will be divided into 2 groups which are group who is given the oral beta-carotene 25,000 IU, oral vitamin D3 50,000 IU and oral zinc 50 mg/day for 3 days, and group who is not given the 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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Hyaline membrane disease
timeFrame: 1,5 years
Secondary outcomes:
measure: Feeding Intolerance
timeFrame: 1,5 years
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Persahabatan General Hospital
name: Yuyun Lisnawati
role: STUDY_CHAIR
References: