Preterm Infants May Better Tolerate Warmer Feeds (Prematurity)
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|ClinicalTrials.gov Identifier: NCT03743207|
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prematurity Feeding Disorder Neonatal||Other: Room temperature Other: Warmer temperature||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, 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.|
|Primary Purpose:||Supportive Care|
|Official Title:||Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial|
|Actual Study Start Date :||October 1, 2012|
|Actual Primary Completion Date :||April 30, 2014|
|Actual Study Completion Date :||April 30, 2014|
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.
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.
Experimental: Warmer 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
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 [ Time Frame: through study completion, an average of 6 months ]Gastric residual volume amount during the study
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743207
|Study Chair:||Ozge Altun Koroglu, M.D.||Ege University|