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

February 20, 2020 updated by: University of Oklahoma

The Effect of a Continuous Milk Warming System on Feeding Tolerance and Growth Rates in Very Low Birth Weight Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

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 Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma, The Children's Hospital

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

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Continuous milk warmer (Guardian Warmer, Medela™)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Gain
Time Frame: At study completion, 10 days.
Comparison of two groups for weight gain over time in grams
At study completion, 10 days.
Feeding Intolerance
Time Frame: At study completion, 10 days
Comparison of feeding tolerance between groups using a residual algorithm
At study completion, 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head Circumference
Time Frame: At study completion, 10 days
frontal-occipital circumference in centimeters
At study completion, 10 days
Body Length
Time Frame: At Study completion, 10 days
Length as measured in centimeters
At Study completion, 10 days

Collaborators and Investigators

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

Sponsor

University of Oklahoma

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 2, 2016

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6748

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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