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Preterm Infants May Better Tolerate Warmer Feeds (Prematurity)

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ClinicalTrials.gov Identifier: NCT03743207
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ozge Altun Koroglu, Ege University

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.

Condition or disease Intervention/treatment Phase
Prematurity Feeding Disorder Neonatal Other: Room temperature Other: Warmer temperature Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Supportive Care
Official Title: Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial
Actual Study Start Date : October 1, 2012
Actual Primary Completion Date : April 30, 2014
Actual Study Completion Date : April 30, 2014

Arm Intervention/treatment
Experimental: Room temperature
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.
Other: Room temperature
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.

Experimental: Warmer temperature
The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature.
Other: Warmer temperature
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 Measures :
  1. 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 Outcome Measures :
  1. Transition time to total enteral feeding [ Time Frame: through study completion, an average of 6 months ]
    The time needed for transition time to total enteral feeding

  2. Daily weight gain [ Time Frame: through study completion, an average of 6 months ]
    The daily weight gain of the infant during the study

  3. Need for anti reflux treatment [ Time Frame: through study completion, an average of 6 months ]
    ıf the infant needed antireflux treatment, the treatment options were recorded

  4. Body weight at discharge [ Time Frame: through study completion, an average of 6 months ]
    Body weight at discharge



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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743207


Locations
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Turkey
Ege University
İzmir, Turkey
Sponsors and Collaborators
Ege University
Investigators
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Study Chair: Ozge Altun Koroglu, M.D. Ege University

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Responsible Party: Ozge Altun Koroglu, Associated Professor, M.D., Ege University
ClinicalTrials.gov Identifier: NCT03743207     History of Changes
Other Study ID Numbers: EGE20121284
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ozge Altun Koroglu, Ege University:
Prematurity
Enteral nutrition
Feeding tolerance
Temperature

Additional relevant MeSH terms:
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Premature Birth
Feeding and Eating Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Mental Disorders