Clinical trial NCT04282655: Effect of Milk Warming on the Very Low Birth Weight Infant
Official title: The Effect of a Continuous Milk Warming System on Feeding Tolerance and Growth Rates in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Very Low Birth Weight Infant
Weight Gain
Feeding Disorder Neonatal
Keywords: breast milk
milk warming
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective quasi-experimental controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Weight Gain
timeFrame: At study completion, 10 days.
measure: Feeding Intolerance
timeFrame: At study completion, 10 days
Secondary outcomes:
measure: Head Circumference
timeFrame: At study completion, 10 days
measure: Body Length
timeFrame: At Study completion, 10 days
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma, The Children's Hospital
state: Oklahoma
Study officials:
affiliation: OUHSC Dept of Pediatrics, Neonatal-Perinatal Medicine
name: Kris Sekar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of Oklahoma, The Children's Hospital
name: Susan M Bedwell, DNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson CA, Berseth CL. Neither motor responses nor gastric emptying vary in response to formula temperature in preterm infants. Biol Neonate. 1996;70(5):265-70. doi: 10.1159/000244375.
citation: Blumenthal I, Lealman GT, Shoesmith DR. Effect of feed temperature and phototherapy on gastric emptying in the neonate. Arch Dis Child. 1980 Jul;55(7):562-4. doi: 10.1136/adc.55.7.562.
citation: Dumm M, Hamms M, Sutton J, Ryan-Wenger N. NICU breast milk warming practices and the physiological effects of breast milk feeding temperatures on preterm infants. Adv Neonatal Care. 2013 Aug;13(4):279-87. doi: 10.1097/ANC.0b013e31829d8c3a.
citation: Eckburg JJ, Bell EF, Rios GR, Wilmoth PK. Effects of formula temperature on postprandial thermogenesis and body temperature of premature infants. J Pediatr. 1987 Oct;111(4):588-92. doi: 10.1016/s0022-3476(87)80127-0.
citation: Bedwell SM, Buster B, Sekar K. The Effect of a Continuous Milk Warming System on Weight Gain in Very Low Birth-Weight Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2021 Aug 1;21(4):E86-E92. doi: 10.1097/ANC.0000000000000818.