Oral vitamin A supllementation versus placebo for preventing for 28 days for preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.

A prospective, multicenter, double blind, placebo-controlled, two-arm parallel group phase 3 trial to evaluate the effect of early postnatal additional high dose oral vitamin A supplementation of 5000 IU/kg/d versus placebo for 28 days for preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants. - NeoVitaA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001998-24-DE

Enrollment

914

Registered

2014-05-16

Start date

2014-10-09

Completion date

Unknown

Last updated

2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.

Interventions

Trade Name: Vitadral® Tropfen Product Name: Vitadral Tropfen Pharmaceutical Form: Oral solution INN or Proposed INN: Retinyl Palmitate Other descriptive name: RETINOL PALMITATE Concentration unit: mg/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Neonates with a birth weight 2.5 / =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: =1 major congenital abnormalities. Congenital nonbacterial infection with overt signs at birth. Terminal illness as evidenced by pH 2 hours or persistent bradycardia (heart rate 2 hours. Birth weight <400 g. Participation in another clinical trial according to German Drug Law (AMG).

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether early postnatal additional high dose oral vitamin A supplementation (5000 IU/kg body weight/day) for 28 days reduces the absolute risk of bronchopulmonary dysplasia (moderate/severe) or death at 36+0 weeks PMA or at date of discharge to home, whichever comes first in ELBW infants when compared to placebo treatment.;Secondary Objective: To assess the impact on high dose oral vitamin A supplementation on: 1.All-cause mortality 2.All grade BPD (mild/moderate/severe) 3.Duration of PPV and PPS 4.Duration of evolving BPD since birth 5.Serum VA status 6.Retinopathy of prematurity (ROP) 7.Intraventricular hemorrhage (IVH) 8.Periventricular leukomalacia (PVL) 9.Necrotizing enterocolitis (NEC) 10.Safety and tolerability of study medication ;Primary end point(s): The primary endpoint of the study is the combined incidence of BPD (moderate/severe) or death at 36+0 weeks PMA or at date of discharge to home, whichever comes first. ;Timepoint(s) of evaluation of this end point: 36+0 weeks	—

Measure

Time frame

Main Objective: To investigate whether early postnatal additional high dose oral vitamin A supplementation (5000 IU/kg body weight/day) for 28 days reduces the absolute risk of bronchopulmonary dysplasia (moderate/severe) or death at 36+0 weeks PMA or at date of discharge to home, whichever comes first in ELBW infants when compared to placebo treatment.;Secondary Objective: To assess the impact on high dose oral vitamin A supplementation on: 1.All-cause mortality 2.All grade BPD (mild/moderate/severe) 3.Duration of PPV and PPS 4.Duration of evolving BPD since birth 5.Serum VA status 6.Retinopathy of prematurity (ROP) 7.Intraventricular hemorrhage (IVH) 8.Periventricular leukomalacia (PVL) 9.Necrotizing enterocolitis (NEC) 10.Safety and tolerability of study medication ;Primary end point(s): The primary endpoint of the study is the combined incidence of BPD (moderate/severe) or death at 36+0 weeks PMA or at date of discharge to home, whichever comes first. ;Timepoint(s) of evaluation of this end point: 36+0 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Any death 2. Any occurrence of BPD (mild/moderate/severe) 3. Days of PPV or PPS 4. Days of evolving BPD 5. Serum retinol levels, RBP, RE 6. Diagnosis of ROP using ophthalmological examination 7. Diagnosis of all grades of IVH using cranial ultrasound investigation 8. Diagnosis of PVL using cranial ultrasound investigation 9. Diagnosis of NEC using clinical examination and X-ray investigation 10. Occurrence of any adverse event 11. Total number of antibiotic treatments at 12 and 24 months of c.a. 12. Total number of antibiotic treatments for pulmonary infections at 12 and 24 months of c.a. 13. Total number of hospital admissions at 12 and 24 months of c.a. 14. Total number of hospital admissions for pulmonary infections at 12 and 24 months of c.a. 15. Results of Bayley-II or Bayley III scale at 24 months of c.a. 16. Anthropometric data at 12 and 24 months of c.a. 17. Neurological and non-neurological diseases during the first 12 and 24 months c.a. 18. Use of supportive therapies and specific drug Treatment;Timepoint(s) of evaluation of this end point: 36+0 weeks 12 months corrected age 24 months corrected age	—

Measure

Time frame

Secondary end point(s): 1. Any death 2. Any occurrence of BPD (mild/moderate/severe) 3. Days of PPV or PPS 4. Days of evolving BPD 5. Serum retinol levels, RBP, RE 6. Diagnosis of ROP using ophthalmological examination 7. Diagnosis of all grades of IVH using cranial ultrasound investigation 8. Diagnosis of PVL using cranial ultrasound investigation 9. Diagnosis of NEC using clinical examination and X-ray investigation 10. Occurrence of any adverse event 11. Total number of antibiotic treatments at 12 and 24 months of c.a. 12. Total number of antibiotic treatments for pulmonary infections at 12 and 24 months of c.a. 13. Total number of hospital admissions at 12 and 24 months of c.a. 14. Total number of hospital admissions for pulmonary infections at 12 and 24 months of c.a. 15. Results of Bayley-II or Bayley III scale at 24 months of c.a. 16. Anthropometric data at 12 and 24 months of c.a. 17. Neurological and non-neurological diseases during the first 12 and 24 months c.a. 18. Use of supportive therapies and specific drug Treatment;Timepoint(s) of evaluation of this end point: 36+0 weeks 12 months corrected age 24 months corrected age

—

Countries

Austria, Germany

Contacts

Public ContactPD Dr. med. Sascha Meyer

Saarland University, Department of Pediatrics

sascha.meyer@uks.eu+4968411628313

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026