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Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

This study is currently recruiting participants.
Verified November 2012 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: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition
Preterm Infant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

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 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard Fortification
Standard Fortification
Individualized Fortification
Individualized Fortification

  Eligibility

Ages Eligible for Study:   up to 40 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Preterm Infants in China

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
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: November 16, 2012
Health Authority: China: Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013