Extremely Premature InfantNCT07296393
Vitamin A in Cord Blood and Preterm Outcomes
An observational study of Extremely Premature Infant, run by The First Hospital of Jilin University.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Extremely Premature Infant
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2025to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates (gestational age <32 weeks)
Who may be able to join
- Gestational age <32 weeks Birth at First Hospital of Jilin University Umbilical cord blood sample obtained within 24 h Parental written informed consent
Who cannot join
- Major congenital malformation or chromosomal abnormality Refusal of consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Association Between Umbilical Cord Blood Vitamin A Levels and Adverse Outcomes in Extremely Preterm Infants: A Single-Center Prospective Cohort Study
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.
- Conditions
- Extremely Premature Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extremely Preterm Infants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse neonatal outcome (any of death, moderate-severe BPD, NEC≥stage II, IVH≥grade III, ROP≥stage 3, PVL, hsPDA, culture-proven sepsis)
Measured: From birth to 36 weeks' PMA or discharge, up to 3 months chronological age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extremely Premature InfantStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296393
- Sponsor's protocol ID
- 25K281-001
- Status last verified
- Apr 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Individual data sharing
- No
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.
PubMed 30500928
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Umbilical Cord Blood Vitamin A Levels and Adverse Outcomes in Extremely Preterm Infants: A Single-Center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07296393
- Acronym / sponsor ID
- 25K281-001
- Conditions
- Extremely Premature Infant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremely Preterm Infants | – | – |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates (gestational age <32 weeks)
Key inclusion criteria (1 listed)
- Gestational age <32 weeks Birth at First Hospital of Jilin University Umbilical cord blood sample obtained within 24 h Parental written informed consent
Key exclusion criteria (1 listed)
- Major congenital malformation or chromosomal abnormality Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 30500928Allen 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.
- Individual participant dataSharing planned: No
Related trials for Extremely Premature Infant
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
RecruitingObservational study
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Late-Onset Neonatal Sepsis, Extreme Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Extremely Premature Infant, run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Wu (13134318877, wuhui@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07296393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.