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Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Peking Union Medical College Hospital
Sponsor:
Collaborator:
Mead Johnson Nutrition
Information provided by (Responsible Party):
Danhua Wang, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01731613
First received: November 5, 2012
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.


Condition Intervention
Infant, Premature, Diseases
Dietary Supplement: human milk fortifier

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Assessment of nutrient concentration of human milk [ Time Frame: participants will be followed until discharge, an expected average of 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical assessment of blood sample [ Time Frame: participants will be followed until discharge, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Body Weight [ Time Frame: participants will be followed until discharge, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Body length and Head circumference [ Time Frame: participants will be followed until discharge, an expected average of 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dietary Supplement: human milk fortifier
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 Name: 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)
Dietary Supplement: human milk fortifier
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 Name: HMF

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.

  Eligibility

Ages Eligible for Study:   up to 40 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731613

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Danhua Wang    8610+15910806977      
Principal Investigator: Danhua Wang, professor         
Sponsors and Collaborators
Peking Union Medical College Hospital
Mead Johnson Nutrition
Investigators
Principal Investigator: Danhua Wang, Professor Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Danhua Wang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01731613     History of Changes
Other Study ID Numbers: 8648
Study First Received: November 5, 2012
Last Updated: October 29, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on November 25, 2014