Vitamin A for BPD Prevention

NCT ID: NCT04563429

Last Updated: 2020-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-10-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group

Group Type: EXPERIMENTAL

Oral Vitamin A

Intervention Type: DIETARY_SUPPLEMENT

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

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral Vitamin A

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 5 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Leah Leibovitch MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leah Leibovich, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center, Tel Hashomer, Israel

Central Contacts

Leah Leibovitch, MD

Role: CONTACT

leah.leibovitch@sheba.health.gov.il

+972526667325

Liudmila Lo Schiavo Winer, MD

Role: CONTACT

Liudmila.LoSchiavo@sheba.health.gov.il

+972503367233

Other Identifiers

SHEBA-20-7281-LL-CTIL

Identifier Type: -

Identifier Source: org_study_id