Effect of Milk Warming on the Very Low Birth Weight Infant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-02

Study Completion Date

2019-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Very Low Birth Weight Infant Weight Gain Feeding Disorder Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized prospective quasi-experimental controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Standard warming procedure of breast milk in syringe prior to feeding.

Treatment Guardian Milk Warmer (Medela TM)

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.

Group Type EXPERIMENTAL

Treatment Guardian Milk Warmer (Medela TM)

Intervention Type OTHER

Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm)

Interventions

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Treatment Guardian Milk Warmer (Medela TM)

Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm)

Intervention Type OTHER

Control

Standard warming procedure of breast milk in syringe prior to feeding.

Intervention Type OTHER

Other Intervention Names

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Continuous milk warmer (Guardian Warmer, Medela™)

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes