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Clinical Trials/NCT03743207
NCT03743207
Completed
Not Applicable

Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial

Ege University1 site in 1 country80 target enrollmentOctober 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prematurity
Sponsor
Ege University
Enrollment
80
Locations
1
Primary Endpoint
Gastric residual volume in mililitres after every feeding
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Therefore, in this study the investigators aimed to examine the effects of feeding temperature and the possible morbidities.

Detailed Description

Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, the investigators aimed to examine the effects of feeds with warm versus room temperature milk in preterm infants. Infants with a birth weight of ≤1500 g or gestational age of ≤ 34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusive breast milk fed and some received artificial milk. Feeding tolerance of patients in both groups and the consequences were evaluated.

Registry
clinicaltrials.gov
Start Date
October 1, 2012
End Date
April 30, 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ozge Altun Koroglu

Associated Professor, M.D.

Ege University

Eligibility Criteria

Inclusion Criteria

  • Infants born to birth weight of ≤1500 g
  • Infants born to gestational age of ≤ 34 weeks

Exclusion Criteria

  • Genetic syndrome
  • Gastrointestinal system anomalies
  • Patients born small for their gestational age

Outcomes

Primary Outcomes

Gastric residual volume in mililitres after every feeding

Time Frame: through study completion, an average of 6 months

Gastric residual volume amount during the study

Secondary Outcomes

  • Body weight at discharge(through study completion, an average of 6 months)
  • Transition time to total enteral feeding(through study completion, an average of 6 months)
  • Need for anti reflux treatment(through study completion, an average of 6 months)
  • Daily weight gain(through study completion, an average of 6 months)

Study Sites (1)

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