Using a New Human Milk Fortifier to Optimize Feeding

Fudan University

Status: Completed

Conditions: Preterm Infant; Growth

Treatments: Dietary Supplement: A new human milk fortifier

Study type: Interventional

Funder types: Other

Identifiers

NCT04283799

NES-SR

Details and patient eligibility

About

This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.

Full 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.

Enrollment: 276 patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

The new HMF group

Experimental group

Description:

Very 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.

Treatment:

Dietary Supplement: A new human milk fortifier

Other HMF group

No Intervention group

Description:

This 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.