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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03366584
Other study ID # 190/2016
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 2017
Est. completion date June 2019

Study information

Verified date August 2018
Source Indonesia University
Contact Yuyun Lisnawati
Email yulisna.er@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Beta carotene
Beta carotene 25,000 IU
Vitamin D3
Vitamin D3 50,000 IU
Zinc
Zinc 50 mg
Drug:
Dexamethasone
Dexamethasone 6 mg

Locations

Country Name City State
Indonesia Cipto Mangunkusumo General Hospital Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hyaline membrane disease The presence and severity of RDS (HMD) will be noted, according to chest X-ray result 1,5 years
Secondary Feeding Intolerance The presence and severity of necrotican enterocolitis will be noted, according to abdominal x-ray result 1,5 years
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