Recruiting

Feed Warming Method

Sponsor:

Advocate Center for Pediatric Research

Code:

NCT02034903

Conditions

Enteral Feeding

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Feedings warmed with commercial warmer

Study Details

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.

Conditions

Enteral Feeding

Study ID

NCT02034903

Start date

Nov, 2013

Status verified date

Jan, 2014

Primary completion date

Nov, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard warming

Feeding warmed in water bath

experimental: Commercial warmer

Feedings warmed with a commercial warmer

Interventions

Feedings warmed with commercial warmer

Primary outcome measure

  • Feeding intolerance [ Time Frame: 168 completed feedings; approximately 28 days ]

Central Contacts and Locations

Locations

Advocate Children's Hospital, Park Ridge

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Principal Investigator:

Bonnie Satinover, BSN

More Information

Sponsor

Advocate Center for Pediatric Research

Last update posted

Jan 14, 2014

Last verified

Jan, 2014

Keywords

  • Enteral Feeding
  • Infant, Premature

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Advocate Center for Pediatric Research on 2014-01-14.