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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04282655
Other study ID # 6748
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 Warmerâ„¢, 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.

Study Design


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
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