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Preterm Infants May Better Tolerate Warmer Feeds (Prematurity)

Primary Purpose

Prematurity, Feeding Disorder Neonatal

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Room temperature
Warmer temperature
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prematurity focused on measuring Prematurity, Enteral nutrition, Feeding tolerance, Temperature

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Room temperature

Warmer temperature

Arm Description

All of the infants in neonatal intensive care units are used to be fed with milk at 22-24°C which is close to room temperature.

The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature.

Outcomes

Primary Outcome Measures

Gastric residual volume in mililitres after every feeding
Gastric residual volume amount during the study

Secondary Outcome Measures

Transition time to total enteral feeding
The time needed for transition time to total enteral feeding
Daily weight gain
The daily weight gain of the infant during the study
Need for anti reflux treatment
ıf the infant needed antireflux treatment, the treatment options were recorded
Body weight at discharge
Body weight at discharge

Full Information

First Posted
October 30, 2018
Last Updated
November 13, 2018
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT03743207
Brief Title
Preterm Infants May Better Tolerate Warmer Feeds
Acronym
Prematurity
Official Title
Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
April 30, 2014 (Actual)
Study Completion Date
April 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Feeding Disorder Neonatal
Keywords
Prematurity, Enteral nutrition, Feeding tolerance, Temperature

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The infants were randomly assigned using the last digit of their hospital identification number to two different groups with different feeding temperatures. Only the nurse giving the primary care was not blinded.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Room temperature
Arm Type
Experimental
Arm Description
All of the infants in neonatal intensive care units are used to be fed with milk at 22-24°C which is close to room temperature.
Arm Title
Warmer temperature
Arm Type
Experimental
Arm Description
The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature.
Intervention Type
Other
Intervention Name(s)
Room temperature
Intervention Description
These infants were fed with room temperature (22-24 °C) so that hypothesizing that they will have more feeding tolerance and therefore more co-existing morbidities.
Intervention Type
Other
Intervention Name(s)
Warmer temperature
Intervention Description
Fifteen NICU mothers volunteered and expressed their milk for rapid measurement of freshly expressed breast milk. The mean (± SD) temperature of freshly expressed breast milk was found to be 33±1.5 °C in these preliminary measurements. Confirming this finding, the investigators decided to feed these infants with milk at 32 - 34 °C to examine the effects of feeding temperature and the possible comorbidities with a hypothesis that warmer feeding at the temperature of freshly expressed breast milk may be better physiologically.
Primary Outcome Measure Information:
Title
Gastric residual volume in mililitres after every feeding
Description
Gastric residual volume amount during the study
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Transition time to total enteral feeding
Description
The time needed for transition time to total enteral feeding
Time Frame
through study completion, an average of 6 months
Title
Daily weight gain
Description
The daily weight gain of the infant during the study
Time Frame
through study completion, an average of 6 months
Title
Need for anti reflux treatment
Description
ıf the infant needed antireflux treatment, the treatment options were recorded
Time Frame
through study completion, an average of 6 months
Title
Body weight at discharge
Description
Body weight at discharge
Time Frame
through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Altun Koroglu, M.D.
Organizational Affiliation
Ege University
Official's Role
Study Chair
Facility Information:
Facility Name
Ege University
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Preterm Infants May Better Tolerate Warmer Feeds

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