Respiratory DistressNCT00729989
Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation
A study testing Gastric suctioning in people with Respiratory Distress, run by Benjamin T. Stevens at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress
- What is being tested?
- Gastric suctioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infant with meconium stained amniotic fluid or born by C-section
Who cannot join
- Prematurity
- Congenital Abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Children's Hospital
Iowa City, Iowa, 52242
About this study
Official title: 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.
- Conditions
- Respiratory Distress
- Being tested
- Gastric suctioning
- Keywords
- Meconium Aspiration, Respiratory Distress, Meconium Stained Amniotic Fluid
- Medical subject headings
- Dyspnea, Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric suctioningProcedure or surgery
The stomach will be suctioned shortly following birth with an orogastric tube
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Not described Receives: Procedure: Gastric suctioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Distress
Measured: Birth
Secondary outcomes (3)
Apgar scores
Measured: Birth
Successful feeding/weight gain
Measured: Birth
Hospital length of stay
Measured: Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Project not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DistressStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin T. Stevens
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor-investigator, Benjamin T. Stevens, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729989
- Sponsor's protocol ID
- 200804774
- Status last verified
- Mar 2017
- First submitted
- 5 Aug 2008
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation- A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00729989
- Acronym / sponsor ID
- 200804774
- Conditions
- Respiratory Distress
- Keywords
- Meconium Aspiration, Respiratory Distress, Meconium Stained Amniotic Fluid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project not funded
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Benjamin T. StevensUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Aug 2008 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Procedure: Gastric suctioning |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Term infant with meconium stained amniotic fluid or born by C-section
Key exclusion criteria (2 listed)
- Prematurity
- Congenital Abnormality
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 |
|---|---|---|
| Gastric suctioningThe stomach will be suctioned shortly following birth with an orogastric tube | Procedure or surgery | 2 |
Primary outcome
Respiratory Distress
Time frame: Birth
3 secondary outcomes
Apgar scores
Time frame: Birth
Successful feeding/weight gain
Time frame: Birth
Hospital length of stay
Time frame: Birth
Results and safety
The study was stopped early (reason given: Project not funded). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric suctioning in people with Respiratory Distress, run by Benjamin T. Stevens at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 13 Mar 2017. 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?
The study was stopped early (reason given: Project not funded). Results are not available in the source record.
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?
Respiratory Distress (time frame: Birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2017.