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

Enteral Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02034903
• Other study ID #: 5283
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2014
• Last updated: January 13, 2014
• Start date: November 2013

Study information

• Verified date: January 2014
• Source: Advocate Center for Pediatric Research
• Contact: Bonnie Satinover, BSN
• Phone: 847-723-5386
• Email: bonnie.satinover[@]advocatehealth.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enteral Feeding

Intervention

Other:
• Feedings warmed with commercial warmer

Locations

Country	Name	City	State
United States	Advocate Children's Hospital, Park Ridge	Park Ridge	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Advocate Center for Pediatric Research	Advocate Health Care, Medela AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feeding intolerance	Feeding intolerance is defined by one or more of the following clinical observations: Abdominal distention defined as increase in abdominal girth > 1 cm. since previous nursing assessment; Obvious blood in stool; Persistent regurgitation (>3 consecutive feedings); Significant gastric residuals: 25-50% of feeding volume x 2 consecutive feeds; > 50% of feeding volume x 1 feed	168 completed feedings; approximately 28 days	No
Secondary	Full enteral feeding	The 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.	approximately 28 days	No