Aspiration of Residual Gastric Contents

June 26, 2023 updated by: University of Florida

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Enteral Intake on Day of Life 7
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Days to Reach Full Feeds
Time Frame: baseline to approximately 42 days
Full feeds is defined as 120 milliliters per kilogram per day
baseline to approximately 42 days
Hours Receiving Parenteral Nutrition
Time Frame: Baseline to 42 days
The number of hours participants required parenteral nutriton
Baseline to 42 days
Hours of Central Line Access
Time Frame: Baseline to 42 days
The number of hours participants required central line access
Baseline to 42 days
Highest Alkaline Phosphatase Level
Time Frame: baseline to 42 days
Highest level during the first 42 days
baseline to 42 days
Occurrence of Cholestasis
Time Frame: Baseline to 42 days
Occurrence of cholestatsis defined as a direct bilirubin level > 2 mg/dL
Baseline to 42 days
Level of Direct Bilirubin
Time Frame: Baseline to 42 days. highest value reported
Level of direct bilirubin on routine weekly or biweekly laboratory testing
Baseline to 42 days. highest value reported
Length of Hospital Stay
Time Frame: baseline to approximately 3 months
Days infant remains in hospital
baseline to approximately 3 months
Episodes of Late Onset Sepsis
Time Frame: 4 to 42 days
Episodes of presumed or culture positive sepsis at > 3 days of life
4 to 42 days
Episodes of Necrotizing Enterocolitis
Time Frame: Baseline to 42 days
Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater)
Baseline to 42 days
Episodes of Ventilator Associated Pneumonia
Time Frame: baseline to 42 days
Episodes of ventilator associated pneumonia
baseline to 42 days
Episodes of Aspiration Pneumonia
Time Frame: baseline to 42 days
Episodes of aspiration pneumonia on radiograph
baseline to 42 days
Episodes of a Positive Tracheal Culture
Time Frame: Baseline to 42 days
Episodes of a tracheal culture positive for bacteria
Baseline to 42 days
Episodes of 2 or More Positive Tracheal Aspirate Cultures
Time Frame: Baseline to 42 days
Episodes of 2 or more tracheal cultures positive for bacteria
Baseline to 42 days
Episodes of Bronchopulmonary Dysplasia
Time Frame: Baseline to approximately 3 months
Episodes of bronchopulmonary dysplasia
Baseline to approximately 3 months
Highest Tracheal Pepsin Level
Time Frame: Baseline to 42 days
The highest level of pepsin obtained from endotracheal tube secretions
Baseline to 42 days
Days of Invasive Ventilation
Time Frame: Baseline to approximately 3 months
Number of days infants required invasive ventilation
Baseline to approximately 3 months
Number of Infants Who Died
Time Frame: Baseline to 42 days
Number of infants who died during the 6 weeks study.
Baseline to 42 days
Number of Abdominal Radiographs
Time Frame: baseline to 42 days
number of abdominal radiographs performed
baseline to 42 days
Episodes of Abdominal Distension
Time Frame: Baseline to 42 days
Episodes of increased abdominal girth by 2cm or greater
Baseline to 42 days
Emesis
Time Frame: baseline to 42 days
Number of emesis episodes
baseline to 42 days
Weight
Time Frame: 42 days
Weight at 6 weeks of age. Note infants were born weighing < 1500 grams
42 days
Head Circumference
Time Frame: 42 days
Head circumference at 42 days
42 days
Length
Time Frame: 42 days
Length at 42 days
42 days
Presence of Blood in Stools
Time Frame: baseline to 42 days
Proportion of guaiac positive stools.
baseline to 42 days
Level of Fecal Calprotectin
Time Frame: 42 days
Level of calprotectin in stools
42 days
Serum Gastrin Level
Time Frame: baseline to 21 days
level of gastrin at 3 weeks
baseline to 21 days
Serum Motilin Level
Time Frame: baseline to 21 days
Serum motilin level at 21 days
baseline to 21 days
Fecal S100A12
Time Frame: 42 days
Level of fecal S100A12
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leslie A Parker, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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