NCT07296393

Brief Summary

This single-center prospective cohort study aims to describe the distribution of umbilical-cord blood vitamin A concentrations in extremely preterm infants (\<32 weeks' gestation) and to evaluate whether low cord blood vitamin A is associated with increased risk of neonatal morbidities such as bronchopulmonary dysplasia (BPD), necrotising enterocolitis (NEC), severe intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP), periventricular leukomalacia (PVL), high-grade patent ductus arteriosus (hsPDA), respiratory distress syndrome (RDS), sepsis and death before discharge.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Dec 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

December 9, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

December 22, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

December 9, 2025

Last Update Submit

December 9, 2025

Conditions

Extremely Premature Infant

Outcome Measures

Primary Outcomes (1)

  • Composite adverse neonatal outcome (any of death, moderate-severe BPD, NEC≥stage II, IVH≥grade III, ROP≥stage 3, PVL, hsPDA, culture-proven sepsis)

    From birth to 36 weeks' PMA or discharge, up to 3 months chronological age.

Study Arms (1)

Extremely Preterm Infants

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm neonates (gestational age \<32 weeks)

You may qualify if:

  • Gestational age \<32 weeks Birth at First Hospital of Jilin University Umbilical cord blood sample obtained within 24 h Parental written informed consent

You may not qualify if:

  • Major congenital malformation or chromosomal abnormality Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Allen LH, Miller JW, de Groot L, Rosenberg IH, Smith AD, Refsum H, Raiten DJ. Biomarkers of Nutrition for Development (BOND): Vitamin B-12 Review. J Nutr. 2018 Dec 1;148(suppl_4):1995S-2027S. doi: 10.1093/jn/nxy201.

    PMID: 30500928RESULT

Central Study Contacts

Hui Wu

CONTACT

13134318877wuhui@jlu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

December 10, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

December 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share