Meconium Aspiration and Tracheal Suctioning-Feasibility Study (MATS)

July 29, 2019 updated by: Marya Strand, MD, St. Louis University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

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 5 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Term newborns (>37 weeks of gestation)
  • Delivery through meconium-stained amniotic fluid
  • Mothers >18 years of age

Exclusion Criteria:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate intubation
These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines.
Procedure: Immediate intubation
Infants that are not vigorous at delivery will receive immediate tracheal suctioning
Experimental: Immediate resuscitation
These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning.
Procedure: Immediate resuscitation
Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to identify, consent, enroll and randomize 70% of eligible infants into study.
Time Frame: 18 months
Feasibility measures
18 months
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
18 months

Collaborators and Investigators

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

Sponsor

St. Louis University

Collaborators

American Academy of Pediatrics

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 (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLU-19817

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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