Vitamin A for BPD Prevention

The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04563429
• Other study ID #: SHEBA-20-7281-LL-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: September 2020
• Source: Sheba Medical Center
• Contact: Leah Leibovitch, MD
• Phone: +972526667325
• Email: leah.leibovitch[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Days

Eligibility

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

Related Conditions & MeSH terms

• The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy

Intervention

Dietary Supplement:
• Oral Vitamin A
Oral administration of 5000 EU of Vitamin A during first 28 days of life

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of BPD at 28 days	Chronic pulmonary desease of prematue babies	28 days of life
Primary	Incidence of mortality at 28 days	Death before 28 days of life	28 days of life