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A multicenter randomized controlled clinical trial on the prevention and treatment of necrotizing enterocolitis in preterm Infants born before 32 weeks of gestation using fresh human breast milk

A multicenter randomized controlled clinical trial on the prevention and treatment of necrotizing enterocolitis in preterm Infants born before 32 weeks of gestation using fresh human breast milk

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125593
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

necrotizing enterocolitis

Interventions

Intervention group (exclusive breastfeeding group):Infants should be fed fresh breast milk at least twice daily
all other feeding protocols will strictly follow the same feeding regimen and breast milk fortifier administration schedule as the control group. Fresh breast milk is defined as milk that has not been
Control group (non-exclusive breastfeeding group):Breastfeeding in this group is defined as the use of breast milk that has been refrigerated, frozen, pasteurized, or expressed more than 4 hours prior

Sponsors

Nanjing Women and Children's Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 2 Years

Inclusion criteria

Inclusion criteria: 1. Gestational age less than 32 weeks 2. Admission to the neonatal intensive care unit after birth 3. Mothers in the intervention group are willing to provide fresh breast milk at least twice daily 4. The participant’s guardian consents and is able to comply with the follow-up study protocol

Exclusion criteria

Exclusion criteria: 1. Contraindications for mothers: Breastfeeding should be discontinued in cases of HIV infection or severe medical conditions, such as chronic nephritis, diabetes, malignant tumors, psychiatric disorders, epilepsy, or heart failure; chemotherapy or radiopharmaceutical therapy 2. Contraindications for infants: Such as congenital gastrointestinal malformations; severe asphyxia requiring long-term use of muscle relaxants or high-dose vasopressors; severe allergies; or during the acute phase of an illness; 3. The study participant’s guardian must provide consent and be able to comply with the follow-up study protocol.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of NEC (Bell Grade II or higher);

Secondary

MeasureTime frame
Incidence of late-onset sepsis;Time to achieve total enteral feeding;Length of hospital stay;Mortality rate;Incidence of BPD, ROP, and EOC;Physical Growth and Neurodevelopment;

Countries

China

Contacts

Public ContactShuping Han

Nanjing Women and Children's Healthcare Hospital

shupinghan@njmu.edu.cn+86 135 8520 4767

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026