Using a New Human Milk Fortifier to Optimize Feeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2021-04-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Preterm Infant Growth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The new HMF group

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.

Group Type EXPERIMENTAL

A new human milk fortifier

Intervention Type DIETARY_SUPPLEMENT

Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF

Other HMF group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A new human milk fortifier

Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No