Infant, PrematureNCT01863043

Aspiration of Residual Gastric Contents

A study testing No aspiration of gastric contents and Routine aspiration of gastric contents in people with Infant, Premature and Nutrition, Enteral, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages Up to 3 days
Conditions the study is for: Infant, Premature, Nutrition, Enteral
What is being tested?: No aspiration of gastric contents and Routine aspiration of gastric contents
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2013to 22 Jan 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 3 days
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Infant, Premature, Nutrition, Enteral
Being tested: No aspiration of gastric contents, Routine aspiration of gastric contents
Keywords: Premature Infant, Nutrition, Enteral
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No aspiration of gastric contentsProcedure or surgery
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
Routine aspiration of gastric contentsProcedure or surgery
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.

Study groups in NCT01863043
Study group	Role	What they receive
Routine aspiration of gastric contents	Active comparator	Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. Receives: Procedure: Routine aspiration of gastric contents
No aspiration of gastric contents	Experimental	Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents. Receives: Procedure: No aspiration of gastric contents

What is being measured

The primary outcome is the main question the study is designed to answer.

Enteral Intake on Day of Life 7
The volume in mL/kg of feeds provided to infant on day of life 7
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day of life 42

Secondary outcomes (28)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 201322 Jan 2019

First posted27 May 2013 (estimated)
Study start7 Oct 2013
Primary completion8 Oct 2016
Study completion22 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infant, PrematureStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01863043
Sponsor's protocol ID: IRB201501174- N
Other IDs: 1R01NR014019-01A1
Status last verified: Jun 2023
First submitted: 22 May 2013
Last updated: 28 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 31757473
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.
PubMed 31034045

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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RecruitingObservational study
Growing Little PEAPODS Study
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All Infant, Premature trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants
ClinicalTrials.gov ID: NCT01863043
Acronym / sponsor ID: IRB201501174- N
Conditions: Infant, Premature, Nutrition, Enteral
Keywords: Premature Infant, Nutrition, Enteral
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 7 Oct 2013 (actual)
Primary completion: 8 Oct 2016 (actual)
Study completion: 22 Jan 2019 (actual)
First posted: 27 May 2013 (estimated)
Results: Posted 28 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Routine aspiration of gastric contents	Active comparator	Procedure: Routine aspiration of gastric contentsInfants 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	Experimental	Procedure: No aspiration of gastric contentsInfants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.

Who may qualify

Ages: Up to 3 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No aspiration of gastric contentsInfants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.	Procedure or surgery	No aspiration of gastric contents
Routine aspiration of gastric contentsInfants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.	Procedure or surgery	Routine aspiration of gastric contents

Primary outcome

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
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
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
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
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
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

28 secondary outcomes

Days to Reach Full Feeds
Time frame: baseline to approximately 42 days
Hours Receiving Parenteral Nutrition
Time frame: Baseline to 42 days
Hours of Central Line Access
Time frame: Baseline to 42 days
Highest Alkaline Phosphatase Level
Time frame: baseline to 42 days
Occurrence of Cholestasis
Time frame: Baseline to 42 days
Level of Direct Bilirubin
Time frame: Baseline to 42 days. highest value reported
Length of Hospital Stay
Time frame: baseline to approximately 3 months
Episodes of Late Onset Sepsis
Time frame: 4 to 42 days
Episodes of Necrotizing Enterocolitis
Time frame: Baseline to 42 days
Episodes of Ventilator Associated Pneumonia
Time frame: baseline to 42 days
Episodes of Aspiration Pneumonia
Time frame: baseline to 42 days
Episodes of a Positive Tracheal Culture
Time frame: Baseline to 42 days
Episodes of 2 or More Positive Tracheal Aspirate Cultures
Time frame: Baseline to 42 days
Episodes of Bronchopulmonary Dysplasia
Time frame: Baseline to approximately 3 months
Highest Tracheal Pepsin Level
Time frame: Baseline to 42 days
Days of Invasive Ventilation
Time frame: Baseline to approximately 3 months
Number of Infants Who Died
Time frame: Baseline to 42 days
Number of Abdominal Radiographs
Time frame: baseline to 42 days
Episodes of Abdominal Distension
Time frame: Baseline to 42 days
Emesis
Time frame: baseline to 42 days
Weight
Time frame: 42 days
Head Circumference
Time frame: 42 days
Length
Time frame: 42 days
Presence of Blood in Stools
Time frame: baseline to 42 days
Level of Fecal Calprotectin
Time frame: 42 days
Serum Gastrin Level
Time frame: baseline to 21 days
Serum Motilin Level
Time frame: baseline to 21 days
Fecal S100A12
Time frame: 42 days

Results and safety

Results posted to the registry on 28 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Routine Aspiration of Gastric Contents	74	61
No Aspiration of Gastric Contents	72	60

Primary outcome: Enteral Intake on Day of Life 7

Time frame: Day of life 7. Least squares mean (95% Confidence Interval). Unit: mL/kg per day

Measure	Routine Aspiration of Gastric Contents n = 74	No Aspiration of Gastric Contents n = 69
Value	27.5 (21.8 to 29.5)	22.6 (18.6 to 26.5)

Routine Aspiration of Gastric Contents vs No Aspiration of Gastric Contents: p = 0.27, Mixed Models Analysis

Primary outcome: Enteral Intake on Day of Life 14

Time frame: Day of life 14. Least squares mean (95% Confidence Interval). Unit: mL/kg per day

Measure	Routine Aspiration of Gastric Contents n = 74	No Aspiration of Gastric Contents n = 69
Value	83.2 (72.9 to 93.8)	94.7 (84.3 to 105.2)

Routine Aspiration of Gastric Contents vs No Aspiration of Gastric Contents: p = 0.12, Mixed Models Analysis

Primary outcome: Enteral Intake on Day of Life 21

Time frame: Day of life 21. Least squares mean (95% Confidence Interval). Unit: mL/kg per day

Measure	Routine Aspiration of Gastric Contents n = 74	No Aspiration of Gastric Contents n = 69
Value	109.2 (98.5 to 120)	117.7 (106.9 to 128.5)

Routine Aspiration of Gastric Contents vs No Aspiration of Gastric Contents: p = 0.28, Mixed Models Analysis

Primary outcome: Enteral Intake on Day of Life 28

Time frame: Day of life 28. Least squares mean (95% Confidence Interval). Unit: mL/kg per day

Measure	Routine Aspiration of Gastric Contents n = 74	No Aspiration of Gastric Contents n = 69
Value	119.4 (109.5 to 129.6)	129.6 (119.7 to 139.6)

Routine Aspiration of Gastric Contents vs No Aspiration of Gastric Contents: p = 0.15, Mixed Models Analysis

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: 42 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Routine Aspiration of Gastric Contents	7 of 74 (9.5%)	0 of 74 (0%)	6 of 74
No Aspiration of Gastric Contents	8 of 69 (11.6%)	0 of 69 (0%)	1 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31757473Parker 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.
Derived from this study: PubMed 31034045Parker 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.
Individual participant dataSharing planned: No

Related trials for Infant, Premature

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie A Parker, PhD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enteral Intake on Day of Life 7 (time frame: Day of life 7). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01863043, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.