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Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation

Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02034903
Enrollment
86
Registered
2014-01-14
Start date
2013-11-30
Completion date
Unknown
Last updated
2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding

Keywords

Enteral Feeding, Infant, Premature

Brief summary

The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been shown to vary greatly, and is influenced by individual provider practice. The clinical effect of varying milk temperatures on preterm infant feeding tolerance has not been well studied. The purpose of this study is to examine the effect of warming method, water bath versus commercial warmer and its impact on feeding tolerance. Sample population will include eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned to a control (water bath) or experimental (commercial warmer) group using a randomized sampling scheme. After warming, and just prior to feeding, milk temperatures will be taken and recorded by a trained data recorder. Feeding tolerance will be measured based on gastric residual volume and length of time required to achieve full feeds. Based upon the available evidence, the study investigators hypothesize that warming feeds to a consistent temperature range using commercially available milk warmer will improve feeding tolerance and decrease time to full feedings in preterm infants.

Interventions

OTHERFeedings warmed with commercial warmer

Sponsors

Wake Forest University Health Sciences
CollaboratorOTHER
Medela AG
CollaboratorINDUSTRY
Advocate Center for Pediatric Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Preterm infants born at less than or equal to 30 0/7 weeks gestation * Infants will be enrolled within the first 48 hours of life

Exclusion criteria

* Gastrointestinal anomalies * Lethal malformations * Parental denial of consent or request for removal from study

Design outcomes

Primary

MeasureTime frameDescription
Feeding intolerance168 completed feedings; approximately 28 daysFeeding intolerance is defined by one or more of the following clinical observations: 1. Abdominal distention defined as increase in abdominal girth \> 1 cm. since previous nursing assessment 2. Obvious blood in stool 3. Persistent regurgitation (\>3 consecutive feedings) 4. Significant gastric residuals: 1. 25-50% of feeding volume x 2 consecutive feeds 2. \> 50% of feeding volume x 1 feed

Secondary

MeasureTime frameDescription
Full enteral feedingapproximately 28 daysThe point in time that parenteral nutrition is discontinued based on the judgment that the infant's enteral intake is sufficient to continue growth and development.

Countries

United States

Contacts

Primary ContactBonnie Satinover, BSN
bonnie.satinover@advocatehealth.com847-723-5386
Backup ContactJeanne Wiesbrock, MS, BSN
jeanne.wiesbrock@advocatehealth.com847-723-7046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026