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Effect of Milk Warming on the Very Low Birth Weight Infant

NCT04282655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-02-25

No results posted yet for this study

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.

Conditions

  • Very Low Birth Weight Infant
  • Weight Gain
  • Feeding Disorder Neonatal

Interventions

OTHER

Treatment Guardian Milk Warmer (Medela TM)

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

OTHER

Control

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

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Kris Sekar, MD · OUHSC Dept of Pediatrics, Neonatal-Perinatal Medicine

  • Susan M Bedwell, DNP · Univeristy of Oklahoma, The Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-02
Primary Completion
2019-03-30
Completion
2019-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282655 on ClinicalTrials.gov