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Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants (VITA-BPD)

5. maj 2026 opdateret af: Erhan Calisici

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

209

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Kocaeli
      • Köseköy, Kocaeli, Tyrkiet (Türkiye), 41060
        • Kocaeli City Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vitamin A Group
Preterm infants received oral high-dose vitamin A supplementation in addition to standard neonatal care.
Medicin: Vitamin A
Oral high-dose vitamin A supplementation administered to preterm infants according to the study protocol to reduce the risk of bronchopulmonary dysplasia.
Andre navne:
  • Retinol
Ingen indgriben: Control Group
Preterm infants received standard neonatal care without vitamin A supplementation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bronchopulmonary Dysplasia
Tidsramme: 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
Mortality
Tidsramme: Up to 44 weeks postmenstrual age
All-cause mortality during hospitalization.
Up to 44 weeks postmenstrual age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Mechanical Ventilation
Tidsramme: Up to 44 weeks postmenstrual age
Total duration of invasive mechanical ventilation in days.
Up to 44 weeks postmenstrual age
Length of Hospital Stay
Tidsramme: Up to 44 weeks postmenstrual age
Total duration of hospitalization from birth to discharge in days.
Up to 44 weeks postmenstrual age
Necrotizing Enterocolitis
Tidsramme: Up to 44 weeks postmenstrual age
Incidence of necrotizing enterocolitis diagnosed according to standard clinical criteria.
Up to 44 weeks postmenstrual age
Retinopathy of Prematurity
Tidsramme: Up to 44 weeks postmenstrual age
Incidence of retinopathy of prematurity diagnosed according to standard screening criteria.
Up to 44 weeks postmenstrual age

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Erhan Calisici

Efterforskere

  • Ledende efterforsker: Erhan Calisici, MD, Kocaeli City Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2012

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VITA-BPD-2012

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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