Re-feeding Gastric Residuals in Preterm Infants

Premature; Infant, Light-for-dates Clinical Trial

Official title:

Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420263
• Other study ID #: UAB Neo 004
• Status: Completed
• Phase: N/A
• First received: August 17, 2011
• Last updated: February 7, 2013
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Premature Birth
• Premature; Infant, Light-for-dates

Intervention

Procedure:
• 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 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to establish full enteral feeding	Time required to reach enteral feeding at 120cc/kg/day	Birth to 28 days	No
Secondary	Feeding intolerance	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.	Birth to 28 days	No
Secondary	Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.	Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of < 12 hours.	Birth to 28 days	No
Secondary	Number of days receiving parenteral nutrition	Total number of days or partial day receiving parenteral nutrition	Birth to 28 days	No
Secondary	Duration of hospital stay	Length of hospital stay in days	Birth to 120 days or discharge, whichever occurs first.	No
Secondary	Diagnosis of necrotizing enterocolitis	Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV	Birth to 120 days or discharge, whichever occurs first.	Yes
Secondary	Diagnosis of intestinal perforation	Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.	Birth to 120 days or discharge, whichever occurs first	Yes
Secondary	Death	Death prior to 121 days of age.	Birth to 120 days	Yes