Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants (NCT07538999) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
China200 participantsStarted 2026-04-01
Plain-language summary
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants. This bundle consists of three aspects: individualized and precise human milk feeding, early enteral zinc supplementation, and routine parenteral carnitine supplementation.
Who can participate
Age range
1 Day
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for intervention group:
* (1) Admitted to the Neonatal Department of Children's Hospital of Fudan University during the study period.
* (2) Preterm infants with a gestational age \< 32 weeks or a birth weight \< 1500 g.
* (3) Admitted to the study center within 24 hours after birth.
* (4) Obtained informed consent from family members. Exclusion Criteria for intervention group
* (1) Newborns with severe congenital diseases, severe congenital malformations, chromosomal abnormalities, or genetic metabolic diseases.
* (2) Death or discharge within two weeks after birth.
Inclusion Criteria for control group:
* (1) Admitted to the Neonatal Department of Children's Hospital of Fudan University from January 2025 to December 2025.
* (2) Preterm infants with a gestational age \< 32 weeks or a birth weight \< 1500 g.
* (3) Admitted to the study center within 24 hours after birth. Exclusion Criteria for control group
* (1) Newborns with severe congenital diseases, severe congenital malformations, chromosomal abnormalities, or genetic metabolic diseases.
* (2) Death or discharge within two weeks after birth.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The z-score of weight change from birth to discharge
Timeframe: At baseline and at discharge, approximately corrected gestational age of 36 to 42 weeks