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

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ClinicalTrials.gov Identifier: NCT02034903
Recruitment Status : Unknown
Verified January 2014 by Bonnie Satinover, Advocate Center for Pediatric Research.
Recruitment status was:  Recruiting
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Collaborators:
Advocate Health Care
Medela AG
Information provided by (Responsible Party):
Bonnie Satinover, 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.

Condition or disease Intervention/treatment Phase
Enteral Feeding Other: Feedings warmed with commercial warmer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation
Study Start Date : November 2013
Estimated Primary Completion Date : November 2015

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034903


Contacts
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Contact: Bonnie Satinover, BSN 847-723-5386 bonnie.satinover@advocatehealth.com
Contact: Jeanne Wiesbrock, MS, BSN 847-723-7046 jeanne.wiesbrock@advocatehealth.com

Locations
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United States, Illinois
Advocate Children's Hospital, Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jeanne Wiesbrock, MS    847-723-7046    jeanne.wiesbrock@advocatehealth.com   
Principal Investigator: Bonnie Satinover, BSN         
Sub-Investigator: Jeanne Wiesbrock, MS, BSN         
Sponsors and Collaborators
Advocate Center for Pediatric Research
Advocate Health Care
Medela AG
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Responsible Party: Bonnie Satinover, RN-NIC, Clinician III, NICU, Advocate Center for Pediatric Research
ClinicalTrials.gov Identifier: NCT02034903    
Other Study ID Numbers: 5283
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Bonnie Satinover, Advocate Center for Pediatric Research:
Enteral Feeding
Infant, Premature