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Clinical Trials/NCT01373073
NCT01373073
Completed
Phase 3

Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Abbott Nutrition15 sites in 1 country147 target enrollmentAugust 2011
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ConditionsPreterm Infants

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Preterm Infants
Sponsor
Abbott Nutrition
Enrollment
147
Locations
15
Primary Endpoint
Weight gain
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •700-1500g birth weight
  • •33 weeks or less gestational age
  • •Appropriate for gestational age
  • •Initiate enteral feeds of human milk by 21 days of life
  • •Mother provided exclusive human milk feeds
  • •Parents allow both human milk and study human milk fortifier
  • •Singleton or twin birth

Exclusion Criteria

  • •Feeding preterm infant formula or non-study human milk fortifier
  • •Expected at facility less than 15 days
  • •Congenital anomalies/disease affecting growth and development
  • •5 minute APGAR of 4 or less
  • •Steroid use
  • •Grade III or IV PVH/IVH
  • •Mechanical ventilator dependency
  • •Maternal incapacity
  • •History of major surgery
  • •Confirmed NEC or sepsis

Outcomes

Primary Outcomes

Weight gain

Time Frame: 29 days

Secondary Outcomes

  • Anthropometric variables(29 days)
  • GI tolerance(29 days)

Study Sites (15)

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