Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

November 25, 2017 updated by: Danhua Wang, Peking Union Medical College Hospital
This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.

Study Overview

Status

Completed

Detailed Description

A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • 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

    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

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

Ages Eligible for Study

1 week to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Less than 34 weeks gestational age at birth
  • Birth weight within 800-1800 grams
  • Exclusively or mostly breastfed (greater than 80% if the feeding volume)
  • Tolerated enteral feedings of 60 ml/kg/d
  • Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment
  • Signed Informed Consent

Exclusion Criteria:

  • Small for gestational age
  • Infants currently receiving ventilation therapy
  • Major congenital malformations
  • Suspected or documented systemic or congenital infections
  • Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth
  • Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia
  • Suspected or documented maternal substance abuse
  • Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Fortification
receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study
Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen
Other Names:
  • HMF
Experimental: Adjustable fortification
encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN)
Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen
Other Names:
  • HMF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach 100kcal/kg/d of enteral nutrition
Time Frame: participants will be followed until discharge, an expected average of 2 weeks
Days to reach 100kcal/kg/d of enteral nutrition
participants will be followed until discharge, an expected average of 2 weeks
The weight gain velocity during hospitalization
Time Frame: participants will be followed until discharge, an expected average of 2 weeks
The weight gain velocity(g/kg/d)
participants will be followed until discharge, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The protein and energy ratio of enteral nutrition each week after enrollment
Time Frame: participants will be followed until discharge, an expected average of 2 weeks
The protein and energy ratio(g/100kcal)
participants will be followed until discharge, an expected average of 2 weeks
Time to reach 2000g of body weight
Time Frame: participants will be followed until discharge, an expected average of 2 weeks
Days to reach 2000g of body weight
participants will be followed until discharge, an expected average of 2 weeks
metabolic indicators after enrollment, including BUN,prealbumin, albumin
Time Frame: participants will be followed until discharge, an expected average of 2 weeks
BUN(mmol/L), prealbumin(mg/L), albumin(g/L)
participants will be followed until discharge, an expected average of 2 weeks

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Danhua Wang, Professor, Peking Union Medical College Hospital

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)

August 1, 2012

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 16, 2012

First Posted (Estimate)

November 22, 2012

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 25, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 8648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Infant, Premature, Diseases

Clinical Trials on human milk fortifier

3
Subscribe