Early Nutrition Support for Extremely Preterm Infants
Official title: Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants Based on Best Clinical Practice: a Real Word Study
Run by Children's Hospital of Fudan University · NCT07538999 · Data updated 2026-11-12
This initiative tests a nutrition bundle—personalized breast milk feeding, early zinc supplementation, and routine carnitine supplementation—for very preterm babies to see if it improves growth and development.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 1 Day |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2029 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07538999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born extremely or very preterm (GA <32 weeks or birth weight <1500 g) admitted to the Neonatal Department at the study center within 24 hours of birth.
✕Probably not a fit
Infants with severe congenital diseases or those who die or are discharged within two weeks may not benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project implements a quality improvement bundle to optimize early nutrition in extremely and very preterm infants. It combines individualized human milk feeding, early enteral zinc, and routine parenteral carnitine to support growth, organ function, and neurodevelopment. The approach compares a targeted nutrition bundle in the intervention group to standard nutritional strategies in a control group at a single center. Eligibility focuses on preterm infants under 32 weeks or under 1500 g birth weight admitted within 24 hours of birth. Outcomes target short-term growth metrics and longer-term developmental indicators, aligned with best available clinical practice evidence.
Why it matters
Potential benefit: If successful, this approach could improve growth and neurodevelopmental outcomes for extremely preterm infants by optimizing early nutrition.
How similar studies have gone: Prior neonatal nutrition studies suggest early and targeted nutrition can influence growth and development, supporting this approach as a meaningful but not yet definitive optimization.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Children's Hospital of Fudan University
Shanghai, China Recruiting
Study contacts
- Study coordinator: Junyan Han, Doctor
- Email: jyhan17@fudan.edu.cn
- Phone: 86 13524675569
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Detection of Respiratory Events in Extremely Preterm Infants Using Acoustic Monitoring
A new acoustic monitoring approach is being tested to detect breathing problems in very preterm babies to help NICU teams spot and manage apnea and related events.
-
Improving operational efficiency for elective eye care visits
This project will try simple patient identification tools to cut waiting and total appointment time for people scheduled for elective eye procedures at the Secunderabad unit.
-
Using bubble CPAP sounds to measure airway pressure in premature infants
This project will try to see if the sounds made by bubble CPAP can tell us how much airway pressure very premature infants (born before 32 weeks) are actually receiving.
-
Early lung development in preterm babies with and without fetal growth restriction
This study will test whether ultrasound measurements of fetal lung volume, diaphragm thickness and heart function before 32 weeks can help predict breathing problems and later lung function in preterm babies with or without fetal growth restriction.
-
Promoting healthy eating among higher education students
This study is testing two ways to encourage college students in Belgium to eat healthier and make better food choices over eight weeks.
-
Impact of a non-invasive ventilation method on very preterm infants
This study is testing a new breathing support method for very preterm infants to see if it helps them do better in the short and long term.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.