- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731613
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
Conditions
Intervention / Treatment
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:
|
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:
|
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
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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
Additional Relevant MeSH Terms
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.
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