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Not yet recruiting NCT07296393

Vitamin A in Cord Blood and Preterm Outcomes

Observational Extremely Premature Infant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Extremely Premature Infant. Basic parameters: up to 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Association Between Umbilical Cord Blood Vitamin A Levels and Adverse Outcomes in Extremely Preterm Infants: A Single-Center Prospective Cohort Study

Overview

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.

Primary outcome measures

  • Composite adverse neonatal outcome (any of death, moderate-severe BPD, NEC≥stage II, IVH≥grade III, ROP≥stage 3, PVL, hsPDA, culture-proven sepsis) [Time frame: From birth to 36 weeks' PMA or discharge, up to 3 months chronological age.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Major congenital malformation or chromosomal abnormality Refusal of consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 30500928

Identifiers

NCT: NCT07296393 · 25K281-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗