Effect of Milk Warming on the Very Low Birth Weight Infant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Very Low Birth Weight Infant, Weight Gain, Feeding Disorder Neonatal

Intervention / Treatment
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* Other: Treatment Guardian Milk Warmer (Medela TM)
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized prospective quasi-experimental controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard method of warming breast milk in a hot water bath prior to feeding. | Other: Control<br>* Standard warming procedure of breast milk in syringe prior to feeding.<br>|
| Experimental: Treatment Guardian Milk Warmer (Medela TM)<br>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)<br>* Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm)<br>* Other names: Continuous milk warmer (Guardian Warmer, Medela™);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain | Comparison of two groups for weight gain over time in grams | At study completion, 10 days. | 
| Feeding Intolerance | 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 | frontal-occipital circumference in centimeters | At study completion, 10 days | 
| Body Length | Length as measured in centimeters | At Study completion, 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast milk, milk warming