Preterm Infants May Better Tolerate Warmer Feeds (Prematurity)

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

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.

Study Overview

• Status: Completed
• Conditions: Prematurity; Feeding Disorder Neonatal
• Intervention / Treatment: Other: Room temperature; Other: Warmer temperature

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric residual volume in mililitres after every feeding	Gastric residual volume amount during the study	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transition time to total enteral feeding	The time needed for transition time to total enteral feeding	through study completion, an average of 6 months
Daily weight gain	The daily weight gain of the infant during the study	through study completion, an average of 6 months
Need for anti reflux treatment	ıf the infant needed antireflux treatment, the treatment options were recorded	through study completion, an average of 6 months
Body weight at discharge	Body weight at discharge	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Study Chair: Ozge Altun Koroglu, M.D., Ege University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): April 30, 2014
• Study Completion (Actual): April 30, 2014

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Temperature; Prematurity; Enteral nutrition; Feeding tolerance
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Feeding and Eating Disorders; Premature Birth
• Other Study ID Numbers: EGE20121284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No