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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin A Group | Experimental | Preterm infants received oral high-dose vitamin A supplementation in addition to standard neonatal care. |
|
| Control Group | No Intervention | Preterm infants received standard neonatal care without vitamin A supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin A | Drug | Oral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bronchopulmonary Dysplasia | 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 |
| Mortality | All-cause mortality during hospitalization. | Up to 44 weeks postmenstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Mechanical Ventilation | Total duration of invasive mechanical ventilation in days. | Up to 44 weeks postmenstrual age |
| Length of Hospital Stay | Total duration of hospitalization from birth to discharge in days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erhan Calisici, MD | Kocaeli City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli City Hospital | Köseköy | Kocaeli | 41060 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared due to institutional and ethical restrictions, including patient confidentiality and data protection regulations.
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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Participants were assigned to one of two parallel groups: oral vitamin A supplementation or standard care.
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This study was conducted as an open-label randomized controlled trial.
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|
| Up to 44 weeks postmenstrual age |
| Necrotizing Enterocolitis | Incidence of necrotizing enterocolitis diagnosed according to standard clinical criteria. | Up to 44 weeks postmenstrual age |
| Retinopathy of Prematurity | Incidence of retinopathy of prematurity diagnosed according to standard screening criteria. | Up to 44 weeks postmenstrual age |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |