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

NCT ID: NCT02034903

Last Updated: 2014-01-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Enteral Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard warming

Feeding warmed in water bath

Group Type NO_INTERVENTION

No interventions assigned to this group

Commercial warmer

Feedings warmed with a commercial warmer

Group Type EXPERIMENTAL

Feedings warmed with commercial warmer

Intervention Type OTHER

Interventions

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Feedings warmed with commercial warmer

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Medela AG

INDUSTRY

Sponsor Role collaborator

Advocate Center for Pediatric Research

OTHER

Sponsor Role lead

Responsible Party

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Bonnie Satinover

RN-NIC, Clinician III, NICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Advocate Children's Hospital, Park Ridge

Park Ridge, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bonnie Satinover, BSN

Role: CONTACT

847-723-5386

Jeanne Wiesbrock, MS, BSN

Role: CONTACT

847-723-7046

Facility Contacts

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Jeanne Wiesbrock, MS

Role: primary

847-723-7046

Other Identifiers

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5283

Identifier Type: -

Identifier Source: org_study_id

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