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

January 13, 2014 updated by: Bonnie Satinover, Advocate Center for Pediatric Research
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Children's Hospital, Park Ridge
        • Contact:
        • Principal Investigator:
          • Bonnie Satinover, BSN
        • Sub-Investigator:
          • Jeanne Wiesbrock, MS, BSN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard warming
Feeding warmed in water bath
Experimental: Commercial warmer
Feedings warmed with a commercial warmer
Other: Feedings warmed with commercial warmer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding intolerance
Time Frame: 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
168 completed feedings; approximately 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full enteral feeding
Time Frame: 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.
approximately 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advocate Center for Pediatric Research

Collaborators

Advocate Health Care
Medela AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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