Using a New Human Milk Fortifier to Optimize Feeding
1 other identifier
interventional
276
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
March 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2021
CompletedJune 9, 2021
June 1, 2021
1.1 years
February 23, 2020
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Growth velocity of weight
Weight is tested daily using the same electronic weighing scale in the different study units. Growth velocity of weight is described in g/day.
During the procedure
Secondary Outcomes (21)
Growth velocity of head circumference
During the procedure
Incidence of feeding intolerance
From the start day of feeding to discharge，an average of 50 days
Time to achieve full enteral feeding
During the hospitalization，an average of 20 days
The changes of blood hemoglobin
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum albumin
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
- +16 more secondary outcomes
Study Arms (2)
The new HMF group
EXPERIMENTALVery preterm infants tolerating 80mL/kg/day of enteral feeding for \>24 hours are started to receive the new human milk fortifier. Study procedure is from the first day of full-strength fortification feeding to the 21th days of that.
Other HMF group
NO INTERVENTIONThis group is a historical control group using the other HMF. Infants with similar gestational age, birth weight, feeding start time and length of hospitalization are enrolled into the control group.
Interventions
Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Nanjing Maternal and Child Health Hospital
Nanjing, Jiangsu, 210004, China
Children's Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200062, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai First Maternity and Infant Hosipital
Shanghai, Shanghai Municipality, 200126, China
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Related Publications (1)
Han J, Zhang L, Zhang R, Han S, Zhu J, Hu X, Sun J, Qiu G, Li Z, Yan W, Xie L, Ye X, Gong X, Li L, Bei F, Liu C, Cao Y. Using a new human milk fortifier to optimize human milk feeding among very preterm and/or very low birth weight infants: a multicenter study in China. BMC Pediatr. 2024 Jan 19;24(1):61. doi: 10.1186/s12887-024-04527-2.
PMID: 38243173DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yun Cao, Ph.D., M.D.
Children's Hospital of Fudan University, Shanghai, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2020
First Posted
February 25, 2020
Study Start
March 16, 2020
Primary Completion
April 23, 2021
Study Completion
April 23, 2021
Last Updated
June 9, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share