Re-feeding Gastric Residuals in Preterm Infants

NCT ID: NCT01420263

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-01-31

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.

Conditions

Premature; Infant, Light-for-dates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Re-feeding gastric 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.

Group Type: ACTIVE_COMPARATOR

Re-feeding residuals

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Fresh Feeding Breastmilk or Formula only

Intervention Type: PROCEDURE

In the presence of significant gastric residuals (more than 1/3 of previous feed or \> 2ml), residual volumes will be discarded and fresh breastmilk 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.

Interventions

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.

Intervention Type: PROCEDURE

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 breastmilk 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

Exclusion Criteria

1. Major congenital/chromosomal anomalies;

2. Moribund infant with low likelihood of survival, in the opinion of the clinical team

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ariel Salas, MD

Fellow Instructor, Department of Pediatrics, Division of Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariel A Salas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Namasivayam Ambalavanan, MD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Waldemar A Carlo, MD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Salas AA, Cuna A, Bhat R, McGwin G Jr, Carlo WA, Ambalavanan N. A randomised trial of re-feeding gastric residuals in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F224-8. doi: 10.1136/archdischild-2014-307067. Epub 2014 Dec 31.

Reference Type: DERIVED

PMID: 25552280 (View on PubMed)

Other Identifiers

UAB Neo 004

Identifier Type: -

Identifier Source: org_study_id