Preterm Infants May Better Tolerate Warmer Feeds

Prematurity Clinical Trial

— Prematurity  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743207
• Other study ID #: EGE20121284
• Status: Completed
• Phase: N/A
• Start date: October 1, 2012
• Est. completion date: April 30, 2014

Study information

• Verified date: November 2018
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2014
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorder Neonatal
• Premature Birth
• Prematurity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric residual volume in mililitres after every feeding	Gastric residual volume amount during the study	through study completion, an average of 6 months
Secondary	Transition time to total enteral feeding	The time needed for transition time to total enteral feeding	through study completion, an average of 6 months
Secondary	Daily weight gain	The daily weight gain of the infant during the study	through study completion, an average of 6 months
Secondary	Need for anti reflux treatment	if the infant needed antireflux treatment, the treatment options were recorded	through study completion, an average of 6 months
Secondary	Body weight at discharge	Body weight at discharge	through study completion, an average of 6 months