Meconium Aspiration SyndromeMATSNCT02708563
Meconium Aspiration and Tracheal Suctioning-Feasibility Study
A study testing Immediate intubation and Immediate resuscitation in people with Meconium Aspiration Syndrome, run by St. Louis University.
Trial summary
Feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation. Read more about this study
- Who is it for?
- Ages Up to 5 minutes
- Conditions the study is for
- Meconium Aspiration Syndrome
- What is being tested?
- Immediate intubation and Immediate resuscitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Jul 2021
- 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 5 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term newborns (>37 weeks of gestation)
- Delivery through meconium-stained amniotic fluid
- Mothers >18 years of age
Who cannot join
- No consent from mother
- Infant vigor at delivery (muscle tone and respiratory effort)
- Prenatally diagnosed major anomalies (excluding gastroschisis)
- Plan to not resuscitate infant
- Family does not speak English
About this study
Official title: Meconium Aspiration Syndrome and Non-vigorous Neonates-Pilot Study
Feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation.
Read the detailed description
This will be a pilot feasibility trial of endotracheal intubation and suctioning versus routine resuscitation for term, non-vigorous newborns born through meconium-stained amniotic fluid to compare the incidence of meconium aspiration syndrome, extracorporeal membrane oxygenation or death.
- Conditions
- Meconium Aspiration Syndrome
- Being tested
- Immediate intubation, Immediate resuscitation
- Keywords
- meconium, neonatal resuscitation
- Medical subject headings
- Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate intubationProcedure or surgery
Infants that are not vigorous at delivery will receive immediate tracheal suctioning
Immediate resuscitationProcedure or surgery
Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed
| Study group | Role | What they receive |
|---|---|---|
| Immediate intubation | Experimental | These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines. Receives: Procedure: Immediate intubation |
| Immediate resuscitation | Experimental | These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning. Receives: Procedure: Immediate resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to identify, consent, enroll and randomize 70% of eligible infants into study.
Feasibility measures
Measured: 18 months
The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die
Clinical outcome measure
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startJul 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Inadequate funds allocated for study completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meconium Aspiration SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics
- Responsible party
- Principal investigator, Marya Strand, MD, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708563
- Sponsor's protocol ID
- SLU-19817
- Acronym
- MATS
- Status last verified
- Jul 2019
- First submitted
- 2 Mar 2016
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meconium Aspiration Syndrome and Non-vigorous Neonates-Pilot Study
- ClinicalTrials.gov ID
- NCT02708563
- Acronym / sponsor ID
- MATS / SLU-19817
- Conditions
- Meconium Aspiration Syndrome
- Keywords
- meconium, neonatal resuscitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate funds allocated for study completion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 15 Mar 2016 (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.
Feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation.
Detailed description
This will be a pilot feasibility trial of endotracheal intubation and suctioning versus routine resuscitation for term, non-vigorous newborns born through meconium-stained amniotic fluid to compare the incidence of meconium aspiration syndrome, extracorporeal membrane oxygenation or death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intubation | Experimental | Procedure: Immediate intubationThese infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines. |
| Immediate resuscitation | Experimental | Procedure: Immediate resuscitationThese infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning. |
Who may qualify
- Ages
- Up to 5 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Term newborns (>37 weeks of gestation)
- Delivery through meconium-stained amniotic fluid
- Mothers >18 years of age
Key exclusion criteria (5 listed)
- No consent from mother
- Infant vigor at delivery (muscle tone and respiratory effort)
- Prenatally diagnosed major anomalies (excluding gastroschisis)
- Plan to not resuscitate infant
- Family does not speak English
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 |
|---|---|---|
| Immediate intubationInfants that are not vigorous at delivery will receive immediate tracheal suctioning | Procedure or surgery | Immediate intubation |
| Immediate resuscitationInfants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed | Procedure or surgery | Immediate resuscitation |
Primary outcome
Ability to identify, consent, enroll and randomize 70% of eligible infants into study.
Time frame: 18 months
Feasibility measures
The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die
Time frame: 18 months
Clinical outcome measure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate intubation and Immediate resuscitation in people with Meconium Aspiration Syndrome, run by St. Louis University.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Ability to identify, consent, enroll and randomize 70% of eligible infants into study. (time frame: 18 months). The study lists 2 primary outcomes in all. 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 31 Jul 2019.