University of Oklahoma, The Children's Hospital
Oklahoma City, Oklahoma, 73104, United States
NCT Number: NCT04282655
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.
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All sexes
Interventional
Not applicable
Oklahoma City, Oklahoma, 73104, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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™)
Standard warming procedure of breast milk in syringe prior to feeding.
Time frame: At study completion, 10 days.
Comparison of two groups for weight gain over time in grams
Time frame: At study completion, 10 days
Comparison of feeding tolerance between groups using a residual algorithm
Time frame: At study completion, 10 days
frontal-occipital circumference in centimeters
Time frame: At Study completion, 10 days
Length as measured in centimeters
University of Oklahoma
Other
The Effect of a Continuous Milk Warming System on Feeding Tolerance and Growth Rates in Very Low Birth Weight Infants
Acronym: VLBW
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