Preterm Infants May Better Tolerate Warmer Feeds

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prematurity, Feeding Disorder Neonatal

Intervention / Treatment
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* Other: Room temperature
* Other: Warmer temperature


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Room temperature<br>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<br>* 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.<br>|
| Experimental: Warmer temperature<br>The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature. | Other: Warmer temperature<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prematurity, Enteral nutrition, Feeding tolerance, Temperature