Re-feeding Gastric Residuals in Preterm Infants

The University of Alabama at Birmingham

Status: Completed

Conditions: Premature; Infant, Light-for-dates

Treatments: Procedure: Re-feeding residuals; Procedure: Fresh Feeding Breastmilk or Formula only

Study type: Interventional

Funder types: Other

Identifiers

NCT01420263

UAB Neo 004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Re-feeding gastric residuals

Active Comparator group

Description:

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.

Treatment:

Procedure: Re-feeding residuals

Fresh feeding breastmilk/formula only

Active Comparator group

Description:

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.

Treatment:

Procedure: Fresh Feeding Breastmilk or Formula only