Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

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

ClinicalTrials.gov processed this record on October 16, 2014