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Aspiration of Residual Gastric Contents

Primary Purpose

Infant, Premature, Nutrition, Enteral

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No aspiration of gastric contents
Routine aspiration of gastric contents
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Premature focused on measuring Premature Infant, Nutrition, Enteral

Eligibility Criteria

undefined - 3 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine aspiration of gastric contents

No aspiration of gastric contents

Arm 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.

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

Outcomes

Primary Outcome Measures

Enteral Intake on Day of Life 7
The volume in mL/kg of feeds provided to infant on 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
Enteral Intake on Day of Life 21
The volume in mL/kg of feeds provided to infants on 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
Enteral Intake at Day of Life 35
The volume in mL/kg of feeds provided to infants on 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

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2013
Last Updated
June 26, 2023
Sponsor
University of Florida
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01863043
Brief Title
Aspiration of Residual Gastric Contents
Official Title
Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2013 (Actual)
Primary Completion Date
October 8, 2016 (Actual)
Study Completion Date
January 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Nutrition, Enteral
Keywords
Premature Infant, Nutrition, Enteral

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine aspiration of gastric contents
Arm Type
Active Comparator
Arm 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.
Arm Title
No aspiration of gastric contents
Arm Type
Experimental
Arm Description
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
Intervention Type
Procedure
Intervention Name(s)
No aspiration of gastric contents
Intervention Description
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
Intervention Type
Procedure
Intervention Name(s)
Routine aspiration of gastric contents
Intervention 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.
Primary Outcome Measure Information:
Title
Enteral Intake on Day of Life 7
Description
The volume in mL/kg of feeds provided to infant on day of life 7
Time Frame
Day of life 7
Title
Enteral Intake on Day of Life 14
Description
The volume in mL/kg of feeds provided to infant on day of life 7
Time Frame
Day of life 14
Title
Enteral Intake on Day of Life 21
Description
The volume in mL/kg of feeds provided to infants on day of life 21
Time Frame
Day of life 21
Title
Enteral Intake on Day of Life 28
Description
The volume in mL/kg of feeds provided to the infant on day of life 28
Time Frame
Day of life 28
Title
Enteral Intake at Day of Life 35
Description
The volume in mL/kg of feeds provided to infants on day of life 35
Time Frame
Day of life 35
Title
Enteral Intake on Day of Life 42
Description
The volume in mL/kg of feeds provided to infants on day of life 42
Time Frame
Day of life 42
Secondary Outcome Measure Information:
Title
Days to Reach Full Feeds
Description
Full feeds is defined as 120 milliliters per kilogram per day
Time Frame
baseline to approximately 42 days
Title
Hours Receiving Parenteral Nutrition
Description
The number of hours participants required parenteral nutriton
Time Frame
Baseline to 42 days
Title
Hours of Central Line Access
Description
The number of hours participants required central line access
Time Frame
Baseline to 42 days
Title
Highest Alkaline Phosphatase Level
Description
Highest level during the first 42 days
Time Frame
baseline to 42 days
Title
Occurrence of Cholestasis
Description
Occurrence of cholestatsis defined as a direct bilirubin level > 2 mg/dL
Time Frame
Baseline to 42 days
Title
Level of Direct Bilirubin
Description
Level of direct bilirubin on routine weekly or biweekly laboratory testing
Time Frame
Baseline to 42 days. highest value reported
Title
Length of Hospital Stay
Description
Days infant remains in hospital
Time Frame
baseline to approximately 3 months
Title
Episodes of Late Onset Sepsis
Description
Episodes of presumed or culture positive sepsis at > 3 days of life
Time Frame
4 to 42 days
Title
Episodes of Necrotizing Enterocolitis
Description
Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater)
Time Frame
Baseline to 42 days
Title
Episodes of Ventilator Associated Pneumonia
Description
Episodes of ventilator associated pneumonia
Time Frame
baseline to 42 days
Title
Episodes of Aspiration Pneumonia
Description
Episodes of aspiration pneumonia on radiograph
Time Frame
baseline to 42 days
Title
Episodes of a Positive Tracheal Culture
Description
Episodes of a tracheal culture positive for bacteria
Time Frame
Baseline to 42 days
Title
Episodes of 2 or More Positive Tracheal Aspirate Cultures
Description
Episodes of 2 or more tracheal cultures positive for bacteria
Time Frame
Baseline to 42 days
Title
Episodes of Bronchopulmonary Dysplasia
Description
Episodes of bronchopulmonary dysplasia
Time Frame
Baseline to approximately 3 months
Title
Highest Tracheal Pepsin Level
Description
The highest level of pepsin obtained from endotracheal tube secretions
Time Frame
Baseline to 42 days
Title
Days of Invasive Ventilation
Description
Number of days infants required invasive ventilation
Time Frame
Baseline to approximately 3 months
Title
Number of Infants Who Died
Description
Number of infants who died during the 6 weeks study.
Time Frame
Baseline to 42 days
Title
Number of Abdominal Radiographs
Description
number of abdominal radiographs performed
Time Frame
baseline to 42 days
Title
Episodes of Abdominal Distension
Description
Episodes of increased abdominal girth by 2cm or greater
Time Frame
Baseline to 42 days
Title
Emesis
Description
Number of emesis episodes
Time Frame
baseline to 42 days
Title
Weight
Description
Weight at 6 weeks of age. Note infants were born weighing < 1500 grams
Time Frame
42 days
Title
Head Circumference
Description
Head circumference at 42 days
Time Frame
42 days
Title
Length
Description
Length at 42 days
Time Frame
42 days
Title
Presence of Blood in Stools
Description
Proportion of guaiac positive stools.
Time Frame
baseline to 42 days
Title
Level of Fecal Calprotectin
Description
Level of calprotectin in stools
Time Frame
42 days
Title
Serum Gastrin Level
Description
level of gastrin at 3 weeks
Time Frame
baseline to 21 days
Title
Serum Motilin Level
Description
Serum motilin level at 21 days
Time Frame
baseline to 21 days
Title
Fecal S100A12
Description
Level of fecal S100A12
Time Frame
42 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie A Parker, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32504
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31757473
Citation
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.
Results Reference
derived
PubMed Identifier
31034045
Citation
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.
Results Reference
derived

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Aspiration of Residual Gastric Contents

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