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

Advocate Center for Pediatric Research

Status: Unknown

Conditions: Enteral Feeding

Treatments: Other: Feedings warmed with commercial warmer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02034903

5283

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Standard warming

No Intervention group

Description:

Feeding warmed in water bath

Commercial warmer

Experimental group

Description:

Feedings warmed with a commercial warmer

Treatment:

Other: Feedings warmed with commercial warmer