Vitamin A for BPD Prevention

Vitamin A Oral Supplementation as a Preventive Treatment for Chronic Lung Disease Among Infants Born Before 29 Weeks of Gestation.

Chronic bronchopulmonary dysplasia (BPD) is a very common complication in preterm infants born at a young gestational age, and is a serious disease that impairs respiratory long-term outcome and is associated with higher-frequency neurodevelopmental injury. Lowering the incidence of BPD may improve the health of the preterm babies and neurodevelopmental delay of preterm infants.Vitamin A deficiency may be one of the factors associated with the development of BPD in preterm infants. According to the literature, oral vitamin A administration can lower the incidence of BPD. In our study we plan to give 5000 units of retinol / dose / day, every day for 28 days.

Study Overview

• Status: Not yet recruiting
• Conditions: The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy
• Intervention / Treatment: Dietary supplement: Oral Vitamin A

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leah Leibovitch, MD; Phone Number: +972526667325; Email: leah.leibovitch@sheba.health.gov.il
• Study Contact Backup: Name: Liudmila Lo Schiavo Winer, MD; Phone Number: +972503367233; Email: Liudmila.LoSchiavo@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 5 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Premature babies under 29 weeks, at any birth weight
• A preterm baby is less than 4 days to life

Exclusion Criteria:

• Major congenital malformations
• Known chromosomal disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Treatment Group	Dietary supplement: Oral Vitamin A; Oral administration of 5000 EU of Vitamin A during first 28 days of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of BPD at 28 days	Chronic pulmonary desease of prematue babies	28 days of life
Incidence of mortality at 28 days	Death before 28 days of life	28 days of life

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Leah Leibovich, MD, Chaim Sheba Medical Center, Tel Hashomer, Israel

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: SHEBA-20-7281-LL-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No