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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04563429
Enrollment
100
Registered
2020-09-24
Start date
2020-10-01
Completion date
2023-10-01
Last updated
2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DIETARY_SUPPLEMENTOral Vitamin A

Oral administration of 5000 EU of Vitamin A during first 28 days of life

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Days to 5 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of BPD at 28 days28 days of lifeChronic pulmonary desease of prematue babies
Incidence of mortality at 28 days28 days of lifeDeath before 28 days of life

Contacts

Primary ContactLeah Leibovitch, MD
leah.leibovitch@sheba.health.gov.il+972526667325
Backup ContactLiudmila Lo Schiavo Winer, MD
Liudmila.LoSchiavo@sheba.health.gov.il+972503367233

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026