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Preterm Infants May Better Tolerate Warmer Feeds

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03743207
Acronym
Prematurity
Enrollment
80
Registered
2018-11-16
Start date
2012-10-01
Completion date
2014-04-30
Last updated
2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity, Feeding Disorder Neonatal

Keywords

Prematurity, Enteral nutrition, Feeding tolerance, Temperature

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.

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

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.

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.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gastric residual volume in mililitres after every feedingthrough study completion, an average of 6 monthsGastric residual volume amount during the study

Secondary

MeasureTime frameDescription
Transition time to total enteral feedingthrough study completion, an average of 6 monthsThe time needed for transition time to total enteral feeding
Daily weight gainthrough study completion, an average of 6 monthsThe daily weight gain of the infant during the study
Need for anti reflux treatmentthrough study completion, an average of 6 monthsıf the infant needed antireflux treatment, the treatment options were recorded
Body weight at dischargethrough study completion, an average of 6 monthsBody weight at discharge

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026