Status:
COMPLETED
Using a New Human Milk Fortifier to Optimize Feeding
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Preterm Infant
Growth
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.
Detailed Description
Infants with fortified human milk feeding have the same rate of growth, lower incidence of nosocomial infections and feeding intolerance compared to those with formula feeding during hospitalization. ...
Eligibility Criteria
Inclusion
- Infants with gestational age between 28+0 weeks to 31+6 weeks, and 1000g≤ birth weight\<1500g;
- Delivered in the study centers or transfer to the study centers within 24 hours after birth;
- Own mother's milk or human milk bank were available;
- Only one of the twins is selected in this study;
- Informed consent has been obtained.
Exclusion
- Severe congenital malformations, severe asphyxia, intracranial hemorrhage and other diseases;
- Small for gestational age infants (birth weight below the 10th percentile of the reference, Fenton premature infant growth chart (2013)）;
- Enteral feeding is not tolerated in 14 days after birth;
- Infants who have participated in other clinical trials within 1 month;
- Other conditions not suitable for this study.
Key Trial Info
Start Date :
March 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2021
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT04283799
Start Date
March 16 2020
End Date
April 23 2021
Last Update
June 9 2021
Active Locations (7)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
2
Nanjing Maternal and Child Health Hospital
Nanjing, Jiangsu, China, 210004
3
Children's Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200062
4
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092