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OpenTrials
Completed

NCT Number: NCT03743207

Preterm Infants May Better Tolerate Warmer Feeds

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.

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Key information

Conditions

Prematurity Feeding Disorder Neonatal Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Acronym: Prematurity

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 16, 2018
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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