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Effect of Milk Warming on the Very Low Birth Weight Infant (VLBW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282655
Recruitment Status : Completed
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard method does not keep the breast milk at a consistent temperature during the feeding. A continuous milk warmer maintains the breast milk at body temperature throughout the feeding. It is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.

Condition or disease Intervention/treatment Phase
Very Low Birth Weight Infant Weight Gain Feeding Disorder Neonatal Other: Treatment Guardian Milk Warmer (Medela TM) Other: Control Not Applicable

Detailed Description:

The aim of this randomized prospective quasi-experimental study is to determine if providing body temperature breast milk feedings to very low birth weight infants through use of continuous milk warmer improves feeding tolerance and weight gain compared to a standard milk warming technique.

Warming breast milk in a hot water bath just prior to feeding prior to feeding in the neonatal intensive care unit is a common practice. However, little evidence is available to support a standard warming method. This method allows inconsistent temperatures at time of feeding and progressive cooling of the milk during the feeding. No published study used a continuous warming device that delivered milk at a consistent physiological temperature throughout the feeding. The continuous warmer externally heats milk in the tubing just posterior to the feeding tube to provide body temperature milk to the infant.

A convenience sample from the Children's Hospital at OU Medical Center of 50 very low birth weight infants will be randomly assigned to either the experimental or control group for ten days. The experimental group will receive warmed feedings through the duration of the feeding through the use of the Guardian Warmer™, a continuous milk warming device. A control group will receive breast milk feedings warmed using the standard milk warming methods. Feeding tolerance and weight gain over the ten-day period will be used to evaluate the effectiveness of continuous milk warming.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized prospective quasi-experimental controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Continuous Milk Warming System on Feeding Tolerance and Growth Rates in Very Low Birth Weight Infants
Actual Study Start Date : September 2, 2016
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Standard method of warming breast milk in a hot water bath prior to feeding.
Other: Control
Standard warming procedure of breast milk in syringe prior to feeding.

Experimental: Treatment Guardian Milk Warmer (Medela TM)
External continuous milk warmer that heats milk within the tubing just posterior to the feeding tube to provide milk at body temperature for feeding infusion.
Other: Treatment Guardian Milk Warmer (Medela TM)
Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm)
Other Name: Continuous milk warmer (Guardian Warmer, Medela™)




Primary Outcome Measures :
  1. Weight Gain [ Time Frame: At study completion, 10 days. ]
    Comparison of two groups for weight gain over time in grams

  2. Feeding Intolerance [ Time Frame: At study completion, 10 days ]
    Comparison of feeding tolerance between groups using a residual algorithm


Secondary Outcome Measures :
  1. Head Circumference [ Time Frame: At study completion, 10 days ]
    frontal-occipital circumference in centimeters

  2. Body Length [ Time Frame: At Study completion, 10 days ]
    Length as measured in centimeters



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Gestational age 28-32 weeks on full enteral feeding of breast milk

Exclusion Criteria:

  • Mechanical ventilation
  • Positive End Expiratory Pressure (PEEP)
  • Total parenteral nutrition, or any congenital anomalies
  • Severe to moderate respiratory disease
  • Previous medical or surgical necrotizing enterocolitis.

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): NCT04282655


Locations
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United States, Oklahoma
University of Oklahoma, The Children's Hospital
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Kris Sekar, MD OUHSC Dept of Pediatrics, Neonatal-Perinatal Medicine
Principal Investigator: Susan M Bedwell, DNP Univeristy of Oklahoma, The Children's Hospital
Publications:
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04282655    
Other Study ID Numbers: 6748
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
breast milk
milk warming
Additional relevant MeSH terms:
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Body Weight
Birth Weight
Weight Gain
Feeding and Eating Disorders
Signs and Symptoms
Body Weight Changes
Mental Disorders