Effect of Milk Warming on the Very Low Birth Weight Infant (VLBW)

University of Oklahoma (OU)

Status: Completed

Conditions: Feeding Disorder Neonatal; Very Low Birth Weight Infant; Weight Gain

Treatments: Other: Control; Other: Treatment Guardian Milk Warmer (Medela TM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04282655

6748

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard method of warming breast milk in a hot water bath prior to feeding.

Treatment:

Other: Control

Treatment Guardian Milk Warmer (Medela TM)

Experimental group

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.

Treatment:

Other: Treatment Guardian Milk Warmer (Medela TM)