Back to results

Using a New Human Milk Fortifier to Optimize Feeding

Primary Purpose

Preterm Infant, Growth

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

A new human milk fortifier

About this trial

This is an interventional treatment trial for Preterm Infant

Eligibility Criteria

undefined - 1 Day (Child)All SexesDoes not accept 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.

Sites / Locations

Peking Union Medical College Hospital
Nanjing Maternal and Child Health Hospital
Children's Hospital of Shanghai Jiao Tong University
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai First Maternity and Infant Hosipital
Shanghai Children's Medical Center
Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The new HMF group

Other HMF group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Growth velocity of head circumference

Head circumference is measured weekly using a nonelastic measuring tape placed over the largest circumference of the skull weekly. Growth velocity is described in cm/week.

Incidence of feeding intolerance

Feeding intolerance is defined as feeds being withheld for 24 hours or more due to concerns related to feeding.

Time to achieve full enteral feeding

Infants tolerating 120mL/ kg/day of enteral feeding for >24 hours are defined as full enteral feeding.

The changes of blood hemoglobin

Blood hemoglobin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/dL.

The change of serum albumin

Serum albumin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/L.

The change of serum proalbumin

Serum proalbumin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mg/L.

The change of serum potassium

Serum potassium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

The change of serum sodium

Serum sodium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

The change of serum phosphorus

Serum phosphorus is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

The changes of serum calcium

Serum calcium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

The change of serum alkaline phosphatase

Serum alkaline phosphatase is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as U/L.

The change of blood urea nitrogen

Blood urea nitrogen is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

The changes of cholesterol

Cholesterol is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

The Change of triglyceride.

Triglyceride is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.

Incidence of abnormal body temperature

Axillary temperature is tested by nurses using clinical electronic thermometers once every four hours. Either low body temperature ( <35℃) or high body temperature ( >37.5℃) is abnormal body temperature.

Incidence of apnea

Apnea is defined as premature infants with respiratory arrest of more than 20 seconds, accompanied by a slow heartbeat, purple or pale skin, and decreased muscle tone.

Incidence of abnormal heart rate

Either heart rate increase (>180/min) or decrease (<90/min) is defined as abnormal heart rate.

Incidence of necrotizing enterocolitis (NEC)

NEC is diagnosed according to the Bell's grade scale.

Incidence of bronchopulmonary dysplasia (BPD)

BPD is defined as oxygen requirement at 36 weeks' postconceptional age.

Incidence of sepsis

Both culture confirmed sepsis and clinical sepsis are defined as sepsis in this study.

Incidence of retinopathy of prematurity (ROP)

ROP is diagnosed by ophthalmologists according to fundus examination.

Full Information

NCT ID

NCT04283799

First Posted

February 23, 2020

Last Updated

June 8, 2021

Sponsor

Children's Hospital of Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04283799

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

March 16, 2020 (Actual)

Primary Completion Date

April 23, 2021 (Actual)

Study Completion Date

April 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Infant, Growth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The new HMF group

Arm Type

Experimental

Arm Description

Arm Title

Other HMF group

Arm Type

No Intervention

Arm 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

A new human milk fortifier

Intervention Description

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

Primary Outcome Measure Information:

Title

Growth velocity of weight

Description

Weight is tested daily using the same electronic weighing scale in the different study units. Growth velocity of weight is described in g/day.

Time Frame

During the procedure

Secondary Outcome Measure Information:

Title

Growth velocity of head circumference

Description

Head circumference is measured weekly using a nonelastic measuring tape placed over the largest circumference of the skull weekly. Growth velocity is described in cm/week.

Time Frame

During the procedure

Title

Incidence of feeding intolerance

Description

Feeding intolerance is defined as feeds being withheld for 24 hours or more due to concerns related to feeding.

Time Frame

From the start day of feeding to discharge，an average of 50 days

Title

Time to achieve full enteral feeding

Description

Infants tolerating 120mL/ kg/day of enteral feeding for >24 hours are defined as full enteral feeding.

Time Frame

During the hospitalization，an average of 20 days

Title

The changes of blood hemoglobin

Description

Blood hemoglobin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/dL.

Time Frame