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Study on the growth promoting and safety effects of two prematureinfant formula

A comparative study on the growth promoting and safety effects of two prematureinfant formula

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093296
Enrollment
Unknown
Registered
2024-12-02
Start date
2024-08-29
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None

Interventions

experimental group:In-hospital phase feeding of in-hospital formula for new preterm infants, out-of-hospital phase feeding of out-of-hospital formula for new preterm infants
controlled group:In-hospital phase feeding of traditional preterm infants in-hospital formula, out-of-hospital phase feeding of traditional preterm infants out-of-hospital formula

Sponsors

Shanghai Children’s Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 1~7 days after birth; 2. Gestational age <34 weeks or birth weight <2000g; 3. Expected to be able to receive enteral feeding within the first 7 days after birth; 4. Daily breast milk intake not exceeding 20% of total feeding; 5. Have signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Infants with severe congenital malformations (such as digestive tract anomalies, diaphragmatic hernia, cyanotic congenital heart disease, etc.) or chromosomal abnormalities; 2. Infants who had surgery or required surgery prior to randomization; 3. Infants with severe intracranial hemorrhage (grade III or higher) or hydrocephalus; 4. Infants whose death risk within 72 hours of enrollment was judged by the investigator; 5. Infants whose participation was judged inappropriate by the investigator for other reasons; 6. Parents or guardians who refused to participate in the clinical trial; 7. Infants who had already participated in other clinical studies.

Design outcomes

Primary

MeasureTime frame
anthropometry(Height, Weight, Head circumference);Incidence of EUGR;Z-score (weight for age, length for age, head circumference for age, weight for height);

Secondary

MeasureTime frame
Age at first attainment of complete enteral nutrition (150 ml/kg/d) and corrected gestational age;Length of hospitalisation;Feeding tolerance assessment (gastric residue =50% of previous intake (=2 times in 24 hours));

Countries

China

Contacts

Public ContactFei Bei

Shanghai Children’s Medical Center

fionabei@163.com+86 189 3083 0712

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026