Effect of Milk Warming on the Very Low Birth Weight Infant (VLBW)
|ClinicalTrials.gov Identifier: NCT04282655|
Recruitment Status : Completed
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
|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|
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 (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized prospective quasi-experimental controlled trial|
|Masking:||None (Open Label)|
|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|
Active Comparator: Control
Standard method of warming breast milk in a hot water bath prior to feeding.
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™)
- Weight Gain [ Time Frame: At study completion, 10 days. ]Comparison of two groups for weight gain over time in grams
- Feeding Intolerance [ Time Frame: At study completion, 10 days ]Comparison of feeding tolerance between groups using a residual algorithm
- Head Circumference [ Time Frame: At study completion, 10 days ]frontal-occipital circumference in centimeters
- Body Length [ Time Frame: At Study completion, 10 days ]Length as measured in centimeters
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282655
|United States, Oklahoma|
|University of Oklahoma, The Children's Hospital|
|Oklahoma City, Oklahoma, United States, 73104|
|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|