Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 8, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedJanuary 14, 2014
January 1, 2014
2 years
January 8, 2014
January 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feeding intolerance
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
168 completed feedings; approximately 28 days
Secondary Outcomes (1)
Full enteral feeding
approximately 28 days
Study Arms (2)
Standard warming
NO INTERVENTIONFeeding warmed in water bath
Commercial warmer
EXPERIMENTALFeedings warmed with a commercial warmer
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Gastrointestinal anomalies
- Lethal malformations
- Parental denial of consent or request for removal from study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advocate Center for Pediatric Researchlead
- Wake Forest University Health Sciencescollaborator
- Medela AGcollaborator
Study Sites (1)
Advocate Children's Hospital, Park Ridge
Park Ridge, Illinois, 60068, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN-NIC, Clinician III, NICU
Study Record Dates
First Submitted
January 8, 2014
First Posted
January 14, 2014
Study Start
November 1, 2013
Primary Completion
November 1, 2015
Last Updated
January 14, 2014
Record last verified: 2014-01