Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation

Not Applicable

• Conditions: Enteral Feeding
• Interventions: Other: Feedings warmed with commercial warmer

• Registration Number: NCT02034903
• Lead Sponsor: Advocate Center for Pediatric Research

Brief Summary

The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been shown to vary greatly, and is influenced by individual provider practice. The clinical effect of varying milk temperatures on preterm infant feeding tolerance has not been well studied. The purpose of this study is to examine the effect of warming method, water bath versus commercial warmer and its impact on feeding tolerance. Sample population will include eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned to a control (water bath) or experimental (commercial warmer) group using a randomized sampling scheme. After warming, and just prior to feeding, milk temperatures will be taken and recorded by a trained data recorder. Feeding tolerance will be measured based on gastric residual volume and length of time required to achieve full feeds. Based upon the available evidence, the study investigators hypothesize that warming feeds to a consistent temperature range using commercially available milk warmer will improve feeding tolerance and decrease time to full feedings in preterm infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-13
• Last Update Submitted: 2014-01-13
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14
• Primary Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Preterm infants born at less than or equal to 30 0/7 weeks gestation
• Infants will be enrolled within the first 48 hours of life

Exclusion Criteria

• Gastrointestinal anomalies
• Lethal malformations
• Parental denial of consent or request for removal from study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Commercial warmer	Feedings warmed with commercial warmer	Feedings warmed with a commercial warmer

Primary Outcome Measures

Name	Time	Method
Feeding intolerance	168 completed feedings; approximately 28 days	Feeding intolerance is defined by one or more of the following clinical observations: 1. Abdominal distention defined as increase in abdominal girth \> 1 cm. since previous nursing assessment; 2. Obvious blood in stool; 3. Persistent regurgitation (\>3 consecutive feedings); 4. Significant gastric residuals: 1. 25-50% of feeding volume x 2 consecutive feeds; 2. \> 50% of feeding volume x 1 feed

Secondary Outcome Measures

Name	Time	Method
Full enteral feeding	approximately 28 days	The point in time that parenteral nutrition is discontinued based on the judgment that the infant's enteral intake is sufficient to continue growth and development.

Trial Locations

Locations (1)

Advocate Children's Hospital, Park Ridge; 🇺🇸 Park Ridge, Illinois, United States