Aspiration of Residual Gastric Contents

University of Florida

Status: Completed

Conditions: Infant, Premature; Nutrition, Enteral

Treatments: Procedure: No aspiration of gastric contents; Procedure: Routine aspiration of gastric contents

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01863043

IRB201501174- N

1R01NR014019-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.

Full description

The participants in the study will be randomly assigned (like the flip of a coin) to either have the leftover food in their stomach removed before each feeding, or not have the leftover food removed before each feeding. In addition, when a blood drawn is performed as regular care an extra amount with be taken. A test to determine how much of the hormones gastrin and motilin are contained in the blood will be performed. Stool samples will be collected. Participation could last up to approximately 6 to 8 weeks of age.

Enrollment: 146 patients

Sex: All

Ages: Under 3 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• born at 32 weeks of less of gestational age
• birth weight </= to 1250 grams
• receiving some enteral feedings by 72 hours of age
• receiving parenteral feedings by 24 hours of age

Exclusion criteria

• Congenital or chromosomal abnormalities
• complex congenital heart diseases and congenital anatomic gastrointestinal abnormalities

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

146 participants in 2 patient groups

Routine aspiration of gastric contents

Active Comparator group

Description:

Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.

Treatment:

Procedure: Routine aspiration of gastric contents

No aspiration of gastric contents

Experimental group

Description:

Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.

Treatment:

Procedure: No aspiration of gastric contents