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Clinical Trials/NCT01759134
NCT01759134
Terminated
Phase 4

Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas

Shaare Zedek Medical Center1 site in 1 country30 target enrollmentJanuary 2013
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ConditionsPremature Birth of Newborn

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Premature Birth of Newborn
Sponsor
Shaare Zedek Medical Center
Enrollment
30
Locations
1
Primary Endpoint
growth
Status
Terminated
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

Detailed Description

Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
  • •Gestational week 30-34.

Exclusion Criteria

  • •Congenital major malformation (e.g. congenital heart disease).
  • •Chromosomal abnormality (e.g. Down's syndrome)
  • •Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
  • •Milk allergy
  • •Chronic disease (e.g. oxygen treatment)

Outcomes

Primary Outcomes

growth

Time Frame: 3 months post discharge

weight (kg), length (cm), head circumference (cm).

Study Sites (1)

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