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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Kocaeli
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Köseköy、Kocaeli、トルコ（Türkiye）、41060
- Kocaeli City Hospital
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Vitamin A Group
Preterm infants received oral high-dose vitamin A supplementation in addition to standard neonatal care.
|
Oral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia.
他の名前：
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介入なし：Control Group
Preterm infants received standard neonatal care without vitamin A supplementation.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bronchopulmonary Dysplasia
時間枠：At 36 weeks postmenstrual age
|
Incidence of bronchopulmonary dysplasia defined as the need for supplemental oxygen at 36 weeks postmenstrual age according to standard diagnostic criteria.
|
At 36 weeks postmenstrual age
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Mortality
時間枠：Up to 44 weeks postmenstrual age
|
All-cause mortality during hospitalization.
|
Up to 44 weeks postmenstrual age
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Duration of Mechanical Ventilation
時間枠：Up to 44 weeks postmenstrual age
|
Total duration of invasive mechanical ventilation in days.
|
Up to 44 weeks postmenstrual age
|
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Length of Hospital Stay
時間枠：Up to 44 weeks postmenstrual age
|
Total duration of hospitalization from birth to discharge in days.
|
Up to 44 weeks postmenstrual age
|
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Necrotizing Enterocolitis
時間枠：Up to 44 weeks postmenstrual age
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Incidence of necrotizing enterocolitis diagnosed according to standard clinical criteria.
|
Up to 44 weeks postmenstrual age
|
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Retinopathy of Prematurity
時間枠：Up to 44 weeks postmenstrual age
|
Incidence of retinopathy of prematurity diagnosed according to standard screening criteria.
|
Up to 44 weeks postmenstrual age
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Erhan Calisici, MD、Kocaeli City Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- VITA-BPD-2012
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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