Preterm Infants May Better Tolerate Warmer Feeds

NCT03743207 | Completed

• 1 other identifier: EGE20121284
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Feeding Disorder Neonatal

Keywords

Prematurity; Enteral nutrition; Feeding tolerance; Temperature

Outcome Measures

Primary Outcomes (1)

• Gastric residual volume in mililitres after every feeding

  Gastric residual volume amount during the study

  through study completion, an average of 6 months

Secondary Outcomes (4)

• Transition time to total enteral feeding

  through study completion, an average of 6 months

• Daily weight gain

  through study completion, an average of 6 months

• Need for anti reflux treatment

  through study completion, an average of 6 months

• Body weight at discharge

  through study completion, an average of 6 months

Study Arms (2)

Room temperature

EXPERIMENTAL

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

Warmer temperature

EXPERIMENTAL

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

Other: Warmer temperature

Interventions

Room temperature OTHER

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.

Room temperature

Warmer temperature OTHER

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.

Warmer temperature

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ozge Altun Koroglu, M.D.

  Ege University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor, M.D.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 16, 2018
• Study Start: October 1, 2012
• Primary Completion: April 30, 2014
• Study Completion: April 30, 2014
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

TU (1)