Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants (VITA-BPD)
Effect of Weekly High-Dose Oral Vitamin A Supplementation on Bronchopulmonary Dysplasia in Very Low Birth Weight Preterm Infants: A Randomized Controlled Trial
Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an increased risk of BPD.
This study aimed to evaluate the effect of prophylactic oral high-dose vitamin A supplementation on the incidence of BPD in preterm infants with a gestational age ≤32 weeks and birth weight <1250 g.
In this randomized controlled trial, preterm infants were assigned to receive either oral vitamin A supplementation or standard care. The primary outcome was the development of BPD. Secondary outcomes included mortality and other neonatal morbidities.
The findings of this study may provide evidence regarding the effectiveness of oral vitamin A supplementation as a simple and accessible strategy to reduce the risk of BPD in preterm infants.
연구 개요
상세 설명
Bronchopulmonary dysplasia (BPD) is a chronic lung disease commonly observed in very low birth weight (VLBW) preterm infants and is associated with significant morbidity and mortality. Vitamin A plays a critical role in lung growth, epithelial differentiation, and repair processes. Previous studies have suggested that vitamin A supplementation may reduce the incidence of BPD, although the optimal route and regimen remain uncertain.
This study was designed as a randomized controlled trial to assess the efficacy of oral high-dose vitamin A supplementation in preventing BPD in preterm infants. Infants with a gestational age of ≤32 weeks and birth weight <1250 g were enrolled and randomly assigned to receive either prophylactic oral vitamin A supplementation or standard neonatal care.
The primary outcome was the incidence of BPD, defined according to standard clinical criteria. Secondary outcomes included mortality, duration of respiratory support, and other neonatal complications.
The results of this study may contribute to the existing evidence on vitamin A supplementation and support the development of accessible and non-invasive preventive strategies for BPD in preterm infants.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Kocaeli
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Köseköy, Kocaeli, 터키 (Türkiye), 41060
- Kocaeli City Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Preterm infants with gestational age ≤32 weeks
- Birth weight ≤1250 grams
- Admitted to the neonatal intensive care unit
- Initiated enteral feeding within the first days of life
Exclusion Criteria:
- Major congenital anomalies
- Chromosomal abnormalities
- Severe perinatal asphyxia
- Inborn errors of metabolism
- Infants who died before initiation of enteral feeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Vitamin A Group
Preterm infants received oral high-dose vitamin A supplementation in addition to standard neonatal care.
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Oral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia.
다른 이름들:
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간섭 없음: Control Group
Preterm infants received standard neonatal care without vitamin A supplementation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bronchopulmonary Dysplasia
기간: At 36 weeks postmenstrual age
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Incidence of bronchopulmonary dysplasia defined as the need for supplemental oxygen at 36 weeks postmenstrual age according to standard diagnostic criteria.
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At 36 weeks postmenstrual age
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Mortality
기간: Up to 44 weeks postmenstrual age
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All-cause mortality during hospitalization.
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Up to 44 weeks postmenstrual age
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of Mechanical Ventilation
기간: Up to 44 weeks postmenstrual age
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Total duration of invasive mechanical ventilation in days.
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Up to 44 weeks postmenstrual age
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Length of Hospital Stay
기간: Up to 44 weeks postmenstrual age
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Total duration of hospitalization from birth to discharge in days.
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Up to 44 weeks postmenstrual age
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Necrotizing Enterocolitis
기간: Up to 44 weeks postmenstrual age
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Incidence of necrotizing enterocolitis diagnosed according to standard clinical criteria.
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Up to 44 weeks postmenstrual age
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Retinopathy of Prematurity
기간: Up to 44 weeks postmenstrual age
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Incidence of retinopathy of prematurity diagnosed according to standard screening criteria.
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Up to 44 weeks postmenstrual age
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Erhan Calisici, MD, Kocaeli City Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VITA-BPD-2012
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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