Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation
March 8, 2017 updated by: Benjamin T. Stevens
Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation- A Randomized Clinical Trial
The stomach of the newborn baby is often emptied soon after birth to prevent breathing problems (respiratory distress).
Babies born with meconium-stained amniotic fluid and those with increased secretions associated with birth by C-section are thought to be at particular risk of breathing problems during the first minutes of life.
Emptying the stomach by sucking out all its contents (gastric suctioning) is alleged to lessen the risk of aspiration and improve respiratory distress.
This study will evaluate the usefulness of gastric suctioning during neonatal resuscitation.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
173
Phase
- 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
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Children's Hospital
-
-
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
Ages Eligible for Study
No older than 1 week (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Term infant with meconium stained amniotic fluid or born by C-section
Exclusion Criteria:
- Prematurity
- Congenital Abnormality
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2
|
The stomach will be suctioned shortly following birth with an orogastric tube
|
|
No Intervention: 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Respiratory Distress
Time Frame: Birth
|
Birth
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Apgar scores
Time Frame: Birth
|
Birth
|
|
Successful feeding/weight gain
Time Frame: Birth
|
Birth
|
|
Hospital length of stay
Time Frame: Birth
|
Birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
August 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
August 5, 2008
First Submitted That Met QC Criteria
August 7, 2008
First Posted (Estimate)
August 8, 2008
Study Record Updates
Last Update Posted (Actual)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 8, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 200804774
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.