Clinical trial NCT01420263: Re-feeding Gastric Residuals in Preterm Infants
Official title: Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature; Infant, Light-for-dates
Keywords: premature infant
feeding
residuals
fresh feeds
full feeds
digestive system
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to establish full enteral feeding
timeFrame: Birth to 28 days
Secondary outcomes:
measure: Feeding intolerance
timeFrame: Birth to 28 days
measure: Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.
timeFrame: Birth to 28 days
measure: Number of days receiving parenteral nutrition
timeFrame: Birth to 28 days
measure: Duration of hospital stay
timeFrame: Birth to 120 days or discharge, whichever occurs first.
measure: Diagnosis of necrotizing enterocolitis
timeFrame: Birth to 120 days or discharge, whichever occurs first.
measure: Diagnosis of intestinal perforation
timeFrame: Birth to 120 days or discharge, whichever occurs first
measure: Death
timeFrame: Birth to 120 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ariel A Salas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Namasivayam Ambalavanan, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_CHAIR
References:
citation: 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.