NCT04282655

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

January 9, 2019

Last Update Submit

February 20, 2020

Conditions

Very Low Birth Weight InfantWeight GainFeeding Disorder Neonatal

Keywords

breast milkmilk warming

Outcome Measures

Primary Outcomes (2)

  • Weight Gain

    Comparison of two groups for weight gain over time in grams

    At study completion, 10 days.

  • Feeding Intolerance

    Comparison of feeding tolerance between groups using a residual algorithm

    At study completion, 10 days

Secondary Outcomes (2)

  • Head Circumference

    At study completion, 10 days

  • Body Length

    At Study completion, 10 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Control

Treatment Guardian Milk Warmer (Medela TM)

EXPERIMENTAL

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.

Other: Treatment Guardian Milk Warmer (Medela TM)

Interventions

Treatment Guardian Milk Warmer (Medela TM)OTHER

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

Also known as: Continuous milk warmer (Guardian Warmer, Medela™)
Treatment Guardian Milk Warmer (Medela TM)
ControlOTHER

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

Control

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age 28-32 weeks on full enteral feeding of breast milk

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma, The Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (5)

  • 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. doi: 10.1159/000244375.

    PMID: 8955912BACKGROUND

  • 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. doi: 10.1136/adc.55.7.562.

    PMID: 7436507BACKGROUND

  • 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.

    PMID: 23912021BACKGROUND

  • 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. doi: 10.1016/s0022-3476(87)80127-0.

    PMID: 3116191BACKGROUND

  • Bedwell SM, Buster B, Sekar K. The Effect of a Continuous Milk Warming System on Weight Gain in Very Low Birth-Weight Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2021 Aug 1;21(4):E86-E92. doi: 10.1097/ANC.0000000000000818.

    PMID: 33427754DERIVED

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kris Sekar, MD

    OUHSC Dept of Pediatrics, Neonatal-Perinatal Medicine

    PRINCIPAL INVESTIGATOR

  • Susan M Bedwell, DNP

    Univeristy of Oklahoma, The Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized prospective quasi-experimental controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

February 25, 2020

Study Start

September 2, 2016

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)