Re-feeding Gastric Residuals in Preterm Infants

Not Applicable

Completed

• Conditions: Premature; Infant, Light-for-dates
• Interventions: Procedure: Re-feeding residuals; Procedure: Fresh Feeding Breastmilk or Formula only

• Registration Number: NCT01420263
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Primary outcome measure is time to establish full enteral feedings (120cc/kg/day).

Detailed Description

Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Feeding advancement determined by clinical physicians.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Gestational age between 23.0 and 28.6 weeks;
2. Receiving intravenous fluids but not enteral nutrition more than trophic feeds;
3. Written informed consent from the parents

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Exclusion Criteria

1. Major congenital/chromosomal anomalies;
2. Moribund infant with low likelihood of survival, in the opinion of the clinical team

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Re-feeding gastric residuals	Re-feeding residuals	In the presence of significant gastric residuals (more than 1/3 of previous feed or \> 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
Fresh feeding breastmilk/formula only	Fresh Feeding Breastmilk or Formula only	In the presence of significant gastric residuals (more than 1/3 of previous feed or \> 2ml), residual volumes will be discarded and fresh breast milk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.

Primary Outcome Measures

Name	Time	Method
Time to establish full enteral feeding	Birth to 28 days	Time required to reach enteral feeding at 120cc/kg/day

Secondary Outcome Measures

Name	Time	Method
Feeding intolerance	Birth to 28 days	Feeding intolerance defined as interruption or cessation of enteral feeds for a perod greater than 12 hours for presence of bloody gastric residuals or an abnormal abdominal examination.
Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.	Birth to 28 days	Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of \< 12 hours.
Number of days receiving parenteral nutrition	Birth to 28 days	Total number of days or partial day receiving parenteral nutrition
Duration of hospital stay	Birth to 120 days or discharge, whichever occurs first.	Length of hospital stay in days
Diagnosis of necrotizing enterocolitis	Birth to 120 days or discharge, whichever occurs first.	Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV
Diagnosis of intestinal perforation	Birth to 120 days or discharge, whichever occurs first	Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.
Death	Birth to 120 days	Death prior to 121 days of age.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States