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

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ClinicalTrials.gov Identifier: NCT03366584
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Yuyun Lisnawati, Indonesia University

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.

Condition or disease Intervention/treatment Phase
Hyaline Membrane Disease Necrotizing Enterocolitis of Newborn Dietary Supplement: Beta carotene Dietary Supplement: Vitamin D3 Dietary Supplement: Zinc Drug: Dexamethasone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Intervention
  • beta carotene 25,000 IU
  • vitamin D3 50,000 IU
  • zinc 50 mg
  • dexamethasone 6 mg
Dietary Supplement: Beta carotene
Beta carotene 25,000 IU

Dietary Supplement: Vitamin D3
Vitamin D3 50,000 IU
Other Name: Cholecalciferol

Dietary Supplement: Zinc
Zinc 50 mg
Other Name: Zinc picolinate

Drug: Dexamethasone
Dexamethasone 6 mg

Active Comparator: Control
dexamethasone 6 mg
Drug: Dexamethasone
Dexamethasone 6 mg




Primary Outcome Measures :
  1. Hyaline membrane disease [ Time Frame: 1,5 years ]
    The presence and severity of RDS (HMD) will be noted, according to chest X-ray result


Secondary Outcome Measures :
  1. Feeding Intolerance [ Time Frame: 1,5 years ]
    The presence and severity of necrotican enterocolitis will be noted, according to abdominal x-ray result



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Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366584


Contacts
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Contact: Yuyun Lisnawati yulisna.er@gmail.com

Locations
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Indonesia
Cipto Mangunkusumo General Hospital Recruiting
Jakarta, DKI Jakarta, Indonesia, 12440
Contact: Yuyun Lisnawati, Consultant    +628161841987    yulisna.er@gmail.com   
Sponsors and Collaborators
Indonesia University
Investigators
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Study Chair: Yuyun Lisnawati Persahabatan General Hospital

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Responsible Party: Yuyun Lisnawati, dr, Indonesia University
ClinicalTrials.gov Identifier: NCT03366584     History of Changes
Other Study ID Numbers: 190/2016
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The research findings will be disseminated via publication of results

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Hyaline Membrane Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Beta Carotene
Dexamethasone
Dexamethasone acetate
BB 1101
Zinc
Carotenoids
Micronutrients
Nutrients
Growth Substances