Using a New Human Milk Fortifier to Optimize Feeding

June 8, 2021 updated by: Children's Hospital of Fudan University

Using a New Human Milk Fortifier to Optimize Human Milk Feeding in Very Preterm Infants, a Multicenter Clinical Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
276

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100730
        • Peking Union Medical College Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200062
        • Children's Hospital of Shanghai Jiao Tong University
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China, 200126
        • Shanghai First Maternity and Infant Hosipital
      • Shanghai, Shanghai, China, 200127
        • Shanghai Children's Medical Center
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 day (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Dietary supplement: 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
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Growth velocity of weight
Time Frame: During the procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Growth velocity of head circumference
Time Frame: During the procedure
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.
During the procedure
Incidence of feeding intolerance
Time Frame: From the start day of feeding to discharge，an average of 50 days
Feeding intolerance is defined as feeds being withheld for 24 hours or more due to concerns related to feeding.
From the start day of feeding to discharge，an average of 50 days
Time to achieve full enteral feeding
Time Frame: During the hospitalization，an average of 20 days
Infants tolerating 120mL/ kg/day of enteral feeding for >24 hours are defined as full enteral feeding.
During the hospitalization，an average of 20 days
The changes of blood hemoglobin
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Blood hemoglobin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/dL.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum albumin
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Serum albumin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as g/L.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum proalbumin
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Serum proalbumin is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mg/L.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum potassium
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Serum potassium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum sodium
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Serum sodium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum phosphorus
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Serum phosphorus is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The changes of serum calcium
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Serum calcium is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of serum alkaline phosphatase
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
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 first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The change of blood urea nitrogen
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
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 first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The changes of cholesterol
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Cholesterol is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
The Change of triglyceride.
Time Frame: The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Triglyceride is tested twice during the procedure. The change is the difference between baseline and after the intervention, described as mmol/L.
The first day of full-strength fortification feeding, the 21th days of full-strength fortification feeding.
Incidence of abnormal body temperature
Time Frame: During the period using HMF, an average of 30 days
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.
During the period using HMF, an average of 30 days
Incidence of apnea
Time Frame: During the period using HMF, an average of 30 days
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.
During the period using HMF, an average of 30 days
Incidence of abnormal heart rate
Time Frame: During the period using HMF, an average of 30 days
Either heart rate increase (>180/min) or decrease (<90/min) is defined as abnormal heart rate.
During the period using HMF, an average of 30 days
Incidence of necrotizing enterocolitis (NEC)
Time Frame: From birth to discharge, an average of 20 days
NEC is diagnosed according to the Bell's grade scale.
From birth to discharge, an average of 20 days
Incidence of bronchopulmonary dysplasia (BPD)
Time Frame: From birth to discharge, an average of 40 days
BPD is defined as oxygen requirement at 36 weeks' postconceptional age.
From birth to discharge, an average of 40 days
Incidence of sepsis
Time Frame: From birth to discharge, an average of 30 days
Both culture confirmed sepsis and clinical sepsis are defined as sepsis in this study.
From birth to discharge, an average of 30 days
Incidence of retinopathy of prematurity (ROP)
Time Frame: From birth to discharge, an average of 40 days
ROP is diagnosed by ophthalmologists according to fundus examination.
From birth to discharge, an average of 40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yun Cao, Ph.D., M.D., Children's Hospital of Fudan University, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NES-SR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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