Preterm Infants May Better Tolerate Warmer Feeds

Overview

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.

Full Title of Study: “Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2014

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Daily weight gain
    • Time Frame: through study completion, an average of 6 months
    • The daily weight gain of the infant during the study
  • 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
  • Body weight at discharge
    • Time Frame: through study completion, an average of 6 months
    • Body weight at discharge

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 30 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ege University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ozge Altun Koroglu, Associated Professor, M.D. – Ege University
  • Overall Official(s)
    • Ozge Altun Koroglu, M.D., Study Chair, Ege University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.