Aspiration of Residual Gastric Contents
Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants
2 other identifiers
interventional
146
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 27, 2013
CompletedStudy Start
First participant enrolled
October 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2019
CompletedResults Posted
Study results publicly available
June 28, 2023
CompletedJune 28, 2023
June 1, 2023
3 years
May 22, 2013
August 5, 2022
June 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (28)
Days to Reach Full Feeds
baseline to approximately 42 days
Hours Receiving Parenteral Nutrition
Baseline to 42 days
Hours of Central Line Access
Baseline to 42 days
Highest Alkaline Phosphatase Level
baseline to 42 days
Occurrence of Cholestasis
Baseline to 42 days
- +23 more secondary outcomes
Study Arms (2)
Routine aspiration of gastric contents
ACTIVE COMPARATORInfants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
No aspiration of gastric contents
EXPERIMENTALInfants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
Interventions
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Congenital or chromosomal abnormalities
- complex congenital heart diseases and congenital anatomic gastrointestinal abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
Gainesville, Florida, 32504, United States
Related Publications (2)
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.
PMID: 31757473DERIVEDParker 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.
PMID: 31034045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Leslie Parker
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie A Parker, PhD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2013
First Posted
May 27, 2013
Study Start
October 7, 2013
Primary Completion
October 8, 2016
Study Completion
January 22, 2019
Last Updated
June 28, 2023
Results First Posted
June 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share