Clinical trial NCT04283799: Using a New Human Milk Fortifier to Optimize Feeding
Official title: Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants, a Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Growth
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 276
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. However, the currently human milk fortifiers (HMF) have some nutritional components defects to meet the needs of very preterm infants. New HMF provide higher protein and fat, which are safe and well tolerate to use in preterm infants. Study on safety and efficacy of the new HMF is insufficient in Chinese preterm infant population. Our aims are to compare the safety and efficacy of a new HMF and other HMF used before in very preterm infants. Very low preterm infants with birth weights of 1000-1499g and gestational age 28+0 weeks to 31 + 6 weeks are included. Infants feeding with new HMF are in the experimental group. Infants feeding with other HMF are in the control group, a historically control group. Physical growth, nutritional indexes, incidence of feeding intolerance, and time to achieve full enteral feeding are compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Growth velocity of weight
timeFrame: During the procedure
Secondary outcomes:
measure: Growth velocity of head circumference
timeFrame: During the procedure
measure: Incidence of feeding intolerance
timeFrame: From the start day of feeding to discharge，an average of 50 days
measure: Time to achieve full enteral feeding
timeFrame: During the hospitalization，an average of 20 days
measure: The changes of blood hemoglobin
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The change of serum albumin
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The change of serum proalbumin
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The change of serum potassium
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The change of serum sodium
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The change of serum phosphorus
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The changes of serum calcium
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The change of serum alkaline phosphatase
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The change of blood urea nitrogen
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The changes of cholesterol
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: The Change of triglyceride.
timeFrame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
measure: Incidence of abnormal body temperature
timeFrame: During the period using HMF, an average of 30 days
measure: Incidence of apnea
timeFrame: During the period using HMF, an average of 30 days
measure: Incidence of abnormal heart rate
timeFrame: During the period using HMF, an average of 30 days
measure: Incidence of necrotizing enterocolitis (NEC)
timeFrame: From birth to discharge, an average of 20 days
measure: Incidence of bronchopulmonary dysplasia (BPD)
timeFrame: From birth to discharge, an average of 40 days
measure: Incidence of sepsis
timeFrame: From birth to discharge, an average of 30 days
measure: Incidence of retinopathy of prematurity (ROP)
timeFrame: From birth to discharge, an average of 40 days
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Children's Hospital of Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hosipital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University, Shanghai, China
name: Yun Cao, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: