Effect of Milk Warming on the Very Low Birth Weight Infant

Weight Gain Clinical Trial

— VLBW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282655
• Other study ID #: 6748
• Status: Completed
• Phase: N/A
• Start date: September 2, 2016
• Est. completion date: March 30, 2019

Study information

• Verified date: February 2020
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Feeding and Eating Disorders
• Feeding Disorder Neonatal
• Very Low Birth Weight Infant
• Weight Gain

Intervention

Other:
• Treatment Guardian Milk Warmer (Medela TM)
Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm)
• Control
Standard warming procedure of breast milk in syringe prior to feeding.

Locations

Country	Name	City	State
United States	University of Oklahoma, The Children's Hospital	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain	Comparison of two groups for weight gain over time in grams	At study completion, 10 days.
Primary	Feeding Intolerance	Comparison of feeding tolerance between groups using a residual algorithm	At study completion, 10 days
Secondary	Head Circumference	frontal-occipital circumference in centimeters	At study completion, 10 days
Secondary	Body Length	Length as measured in centimeters	At Study completion, 10 days