Aspiration of Residual Gastric Contents

Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants

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.

Study Overview

• Status: Completed
• Conditions: Nutrition, Enteral; Infant, Premature
• Intervention / Treatment: Procedure: Routine aspiration of gastric contents; Procedure: No aspiration of gastric contents

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32504
      • Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine aspiration of gastric contents; Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.	Procedure: Routine aspiration of gastric contents; Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Experimental: No aspiration of gastric contents; Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.	Procedure: No aspiration of gastric contents; Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enteral Intake on Day of Life 7	The volume in mL/kg of feeds provided to infant on day of life 7	Day of life 7
Enteral Intake on Day of Life 14	The volume in mL/kg of feeds provided to infant on day of life 7	Day of life 14
Enteral Intake on Day of Life 21	The volume in mL/kg of feeds provided to infants on day of life 21	Day of life 21
Enteral Intake on Day of Life 28	The volume in mL/kg of feeds provided to the infant on day of life 28	Day of life 28
Enteral Intake at Day of Life 35	The volume in mL/kg of feeds provided to infants on day of life 35	Day of life 35
Enteral Intake on Day of Life 42	The volume in mL/kg of feeds provided to infants on day of life 42	Day of life 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to Reach Full Feeds	Full feeds is defined as 120 milliliters per kilogram per day	baseline to approximately 42 days
Hours Receiving Parenteral Nutrition	The number of hours participants required parenteral nutriton	Baseline to 42 days
Hours of Central Line Access	The number of hours participants required central line access	Baseline to 42 days
Highest Alkaline Phosphatase Level	Highest level during the first 42 days	baseline to 42 days
Occurrence of Cholestasis	Occurrence of cholestatsis defined as a direct bilirubin level > 2 mg/dL	Baseline to 42 days
Level of Direct Bilirubin	Level of direct bilirubin on routine weekly or biweekly laboratory testing	Baseline to 42 days. highest value reported
Length of Hospital Stay	Days infant remains in hospital	baseline to approximately 3 months
Episodes of Late Onset Sepsis	Episodes of presumed or culture positive sepsis at > 3 days of life	4 to 42 days
Episodes of Necrotizing Enterocolitis	Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater)	Baseline to 42 days
Episodes of Ventilator Associated Pneumonia	Episodes of ventilator associated pneumonia	baseline to 42 days
Episodes of Aspiration Pneumonia	Episodes of aspiration pneumonia on radiograph	baseline to 42 days
Episodes of a Positive Tracheal Culture	Episodes of a tracheal culture positive for bacteria	Baseline to 42 days
Episodes of 2 or More Positive Tracheal Aspirate Cultures	Episodes of 2 or more tracheal cultures positive for bacteria	Baseline to 42 days
Episodes of Bronchopulmonary Dysplasia	Episodes of bronchopulmonary dysplasia	Baseline to approximately 3 months
Highest Tracheal Pepsin Level	The highest level of pepsin obtained from endotracheal tube secretions	Baseline to 42 days
Days of Invasive Ventilation	Number of days infants required invasive ventilation	Baseline to approximately 3 months
Number of Infants Who Died	Number of infants who died during the 6 weeks study.	Baseline to 42 days
Number of Abdominal Radiographs	number of abdominal radiographs performed	baseline to 42 days
Episodes of Abdominal Distension	Episodes of increased abdominal girth by 2cm or greater	Baseline to 42 days
Emesis	Number of emesis episodes	baseline to 42 days
Weight	Weight at 6 weeks of age. Note infants were born weighing < 1500 grams	42 days
Head Circumference	Head circumference at 42 days	42 days
Length	Length at 42 days	42 days
Presence of Blood in Stools	Proportion of guaiac positive stools.	baseline to 42 days
Level of Fecal Calprotectin	Level of calprotectin in stools	42 days
Serum Gastrin Level	level of gastrin at 3 weeks	baseline to 21 days
Serum Motilin Level	Serum motilin level at 21 days	baseline to 21 days
Fecal S100A12	Level of fecal S100A12	42 days

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Leslie A Parker, PhD, University of Florida

Publications and helpful links

General Publications

• Parker LA, Weaver M, Murgas Torrazza RJ, Shuster J, Li N, Krueger C, Neu J. Effect of Aspiration and Evaluation of Gastric Residuals on Intestinal Inflammation, Bleeding, and Gastrointestinal Peptide Level. J Pediatr. 2020 Feb;217:165-171.e2. doi: 10.1016/j.jpeds.2019.10.036. Epub 2019 Nov 19.
• Parker LA, Weaver M, Murgas Torrazza RJ, Shuster J, Li N, Krueger C, Neu J. Effect of Gastric Residual Evaluation on Enteral Intake in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2019 Jun 1;173(6):534-543. doi: 10.1001/jamapediatrics.2019.0800. Erratum In: JAMA Pediatr. 2019 Jun 1;173(6):610.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2013
• Primary Completion (Actual): October 8, 2016
• Study Completion (Actual): January 22, 2019

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimated): May 27, 2013

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Nutrition; Enteral; Premature Infant
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: IRB201501174- N; 1R01NR014019-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No