Preterm Infants May Better Tolerate Warmer Feeds

Not Applicable

Completed

• Conditions: Prematurity; Feeding Disorder Neonatal
• Interventions: Other: Warmer temperature; Other: Room temperature

• Registration Number: NCT03743207
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2012-10-01
• Primary Completion: 2014-04-30
• Study Completion: 2014-04-30
• Study First Submitted: 2018-10-30
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-16
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warmer temperature	Warmer temperature	The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature.
Room temperature	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.

Primary Outcome Measures

Name	Time	Method
Gastric residual volume in mililitres after every feeding	through study completion, an average of 6 months	Gastric residual volume amount during the study

Secondary Outcome Measures

Name	Time	Method
Body weight at discharge	through study completion, an average of 6 months	Body weight at discharge
Transition time to total enteral feeding	through study completion, an average of 6 months	The time needed for transition time to total enteral feeding
Need for anti reflux treatment	through study completion, an average of 6 months	ıf the infant needed antireflux treatment, the treatment options were recorded
Daily weight gain	through study completion, an average of 6 months	The daily weight gain of the infant during the study

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Turkey