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Completed

NCT Number: NCT04282655

Effect of Milk Warming on the Very Low Birth Weight Infant

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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Key information

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma, The Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment Guardian Milk Warmer (Medela TM)

Other

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

Other names: Continuous milk warmer (Guardian Warmer, Medela™)

Control

Other

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

Primary outcomes

  1. Weight Gain

    Time frame: At study completion, 10 days.

    Comparison of two groups for weight gain over time in grams

  2. Feeding Intolerance

    Time frame: At study completion, 10 days

    Comparison of feeding tolerance between groups using a residual algorithm

Secondary outcomes

  1. Head Circumference

    Time frame: At study completion, 10 days

    frontal-occipital circumference in centimeters

  2. Body Length

    Time frame: At Study completion, 10 days

    Length as measured in centimeters

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: VLBW

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2020
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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