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

NCT03366584 | Unknown Phase 4 DMC

• 1 other identifier: 190/2016
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyaline Membrane Disease; Necrotizing Enterocolitis of Newborn

Outcome Measures

Primary Outcomes (1)

• Hyaline membrane disease

  The presence and severity of RDS (HMD) will be noted, according to chest X-ray result

  1,5 years

Secondary Outcomes (1)

• Feeding Intolerance

  1,5 years

Study Arms (2)

Intervention

EXPERIMENTAL

* 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

Control

ACTIVE COMPARATOR

dexamethasone 6 mg

Drug: Dexamethasone

Interventions

Beta carotene DIETARY_SUPPLEMENT

Beta carotene 25,000 IU

Intervention

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 50,000 IU

Also known as: Cholecalciferol

Intervention

Zinc DIETARY_SUPPLEMENT

Zinc 50 mg

Also known as: Zinc picolinate

Intervention

Dexamethasone DRUG

Dexamethasone 6 mg

Control; Intervention

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta, DKI Jakarta, 12440, Indonesia

RECRUITING

MeSH Terms

Conditions

Hyaline Membrane Disease

Interventions

beta Carotene; Cholecalciferol; Zinc; picolinic acid; Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated

Study Officials

• Yuyun Lisnawati

  Persahabatan General Hospital

  STUDY CHAIR

Central Study Contacts

Yuyun Lisnawati

CONTACT

yulisna.er@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The neonates outcomes, hyaline membrane disease and feeding intolerance, will be assessed for maximum period of 4 weeks by doctor who in charge in NICU. They are outside the research team and blind to maternal treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 8, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

ID (1)