Effect of Milk Warming on the Very Low Birth Weight Infant (VLBW)
Primary Purpose
Very Low Birth Weight Infant, Weight Gain, Feeding Disorder Neonatal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment Guardian Milk Warmer (Medela TM)
Control
Sponsored by
About this trial
This is an interventional treatment trial for Very Low Birth Weight Infant focused on measuring breast milk, 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.
Sites / Locations
- University of Oklahoma, The Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Treatment Guardian Milk Warmer (Medela TM)
Arm Description
Standard method of warming breast milk in a hot water bath prior to feeding.
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.
Outcomes
Primary Outcome Measures
Weight Gain
Comparison of two groups for weight gain over time in grams
Feeding Intolerance
Comparison of feeding tolerance between groups using a residual algorithm
Secondary Outcome Measures
Head Circumference
frontal-occipital circumference in centimeters
Body Length
Length as measured in centimeters
Full Information
NCT ID
NCT04282655
First Posted
January 9, 2019
Last Updated
February 20, 2020
Sponsor
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT04282655
Brief Title
Effect of Milk Warming on the Very Low Birth Weight Infant
Acronym
VLBW
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2, 2016 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infant, Weight Gain, Feeding Disorder Neonatal
Keywords
breast milk, milk warming
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective quasi-experimental controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard method of warming breast milk in a hot water bath prior to feeding.
Arm Title
Treatment Guardian Milk Warmer (Medela TM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment Guardian Milk Warmer (Medela TM)
Other Intervention Name(s)
Continuous milk warmer (Guardian Warmer, Medela™)
Intervention Description
Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm)
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard warming procedure of breast milk in syringe prior to feeding.
Primary Outcome Measure Information:
Title
Weight Gain
Description
Comparison of two groups for weight gain over time in grams
Time Frame
At study completion, 10 days.
Title
Feeding Intolerance
Description
Comparison of feeding tolerance between groups using a residual algorithm
Time Frame
At study completion, 10 days
Secondary Outcome Measure Information:
Title
Head Circumference
Description
frontal-occipital circumference in centimeters
Time Frame
At study completion, 10 days
Title
Body Length
Description
Length as measured in centimeters
Time Frame
At Study completion, 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kris Sekar, MD
Organizational Affiliation
OUHSC Dept of Pediatrics, Neonatal-Perinatal Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan M Bedwell, DNP
Organizational Affiliation
Univeristy of Oklahoma, The Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma, The Children's Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8955912
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.
Results Reference
background
PubMed Identifier
7436507
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.
Results Reference
background
PubMed Identifier
23912021
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.
Results Reference
background
PubMed Identifier
3116191
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.
Results Reference
background
PubMed Identifier
33427754
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.
Results Reference
derived
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Effect of Milk Warming on the Very Low Birth Weight Infant
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