MedDataX Logo

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

NCT ID: NCT03366584

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Zinc Supplementation on Very Low Birth Weight Infant

NCT04050488

Early-Onset Sepses, Neonatal Periventricular Haemorrhage Neonatal Bronchopulmonary Dysplasia +3 more
UNKNOWN PHASE4

Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion

NCT03643458

Blood Transfusion Complication Necrotizing Enterocolitis Enteral Feeding Intolerance +1 more
COMPLETED

Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration

NCT00000563

Lung Diseases Respiratory Distress Syndrome
COMPLETED PHASE3

Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates

NCT01745510

Necrotizing Enterocolitis
COMPLETED PHASE1/PHASE2

Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

NCT00934843

Congenital Heart Disease Disorder of Fetus or Newborn
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyaline Membrane Disease Necrotizing Enterocolitis of Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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

Group Type EXPERIMENTAL

Beta carotene

Intervention Type DIETARY_SUPPLEMENT

Beta carotene 25,000 IU

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 50,000 IU

Zinc

Intervention Type DIETARY_SUPPLEMENT

Zinc 50 mg

Dexamethasone

Intervention Type DRUG

Dexamethasone 6 mg

Control

dexamethasone 6 mg

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 6 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beta carotene

Beta carotene 25,000 IU

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 50,000 IU

Intervention Type DIETARY_SUPPLEMENT

Zinc

Zinc 50 mg

Intervention Type DIETARY_SUPPLEMENT

Dexamethasone

Dexamethasone 6 mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cholecalciferol Zinc picolinate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

17 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yuyun Lisnawati

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuyun Lisnawati

Role: STUDY_CHAIR

Persahabatan General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cipto Mangunkusumo General Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuyun Lisnawati

Role: CONTACT

[email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuyun Lisnawati, Consultant

Role: primary

[email protected]
+628161841987

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

190/2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis
NCT01735578 COMPLETED
Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease
NCT01126372 COMPLETED
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
NCT01579513 COMPLETED NA
Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity
NCT05438680 COMPLETED NA
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
NCT01954017 COMPLETED PHASE1
Strategy to Minimize In-hospital Malnutrition in Premature Babies
NCT01217164 COMPLETED EARLY_PHASE1
Impact of Antenatal Corticosteroid Therapy on Postnatal Surfactant Use in Preterm Infants
NCT05455879 COMPLETED
Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.
NCT02383264 COMPLETED
Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
NCT03767634 COMPLETED
Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes During Invasive Procedures
NCT03010891 COMPLETED NA
Antenatal Dexamethasone for Late Preterm Deliveries
NCT05841121 RECRUITING PHASE1
Nutrition Protocol and Premature Infants' Growth
NCT03217045 COMPLETED
Splanchnic Oxygenation Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler.
NCT02971566 COMPLETED
Antibiotic "Dysbiosis" in Preterm Infants
NCT02784821 COMPLETED PHASE2
Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid
NCT01306500 COMPLETED NA
Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition
NCT02622373 COMPLETED
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
NCT01223261 COMPLETED
Impact of Pre-operative Steroids on Adrenal Insufficiency
NCT02956707 COMPLETED
Duodenal Feeds in Very Low Birth Weight Infants
NCT04246333 ACTIVE_NOT_RECRUITING NA
A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial
NCT04945967 COMPLETED NA
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
NCT07344714 RECRUITING
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
NCT06366880 RECRUITING NA
Adverse Neonatal Outcomes with a Shortened Clinical Regimen of Dexamethasone.
NCT06569251 COMPLETED PHASE2
Effect of Antenatal Corticosteroids in Late Preterm
NCT01710384 UNKNOWN PHASE2
Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Neonates
NCT01628133 COMPLETED