An interventional study of Room temperature and Warmer temperature in Prematurity and Feeding Disorder Neonatal, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2018-11-16.
Sponsored by Ege University · Not applicable, Interventional, and Supportive care
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.
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.
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This study's enrollment of 80 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
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
The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature.
Other: Warmer 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.
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.
Gastric residual volume in mililitres after every feeding
Gastric residual volume amount during the study
Time frame: through study completion, an average of 6 months
Transition time to total enteral feeding
The time needed for transition time to total enteral feeding
Time frame: through study completion, an average of 6 months
Daily weight gain
The daily weight gain of the infant during the study
Time frame: through study completion, an average of 6 months
Need for anti reflux treatment
ıf the infant needed antireflux treatment, the treatment options were recorded
Time frame: through study completion, an average of 6 months
Body weight at discharge
Body weight at discharge
Time frame: through study completion, an average of 6 months
Plan to share: Undecided
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Ege University