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Meconium Aspiration and Tracheal Suctioning-Feasibility Study (MATS)

Primary Purpose

Meconium Aspiration Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immediate intubation
Immediate resuscitation
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meconium Aspiration Syndrome focused on measuring meconium, neonatal resuscitation

Eligibility Criteria

undefined - 5 Minutes (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Immediate intubation

    Immediate resuscitation

    Arm Description

    These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines.

    These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning.

    Outcomes

    Primary Outcome Measures

    Ability to identify, consent, enroll and randomize 70% of eligible infants into study.
    Feasibility measures
    The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die
    Clinical outcome measure

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2016
    Last Updated
    July 29, 2019
    Sponsor
    St. Louis University
    Collaborators
    American Academy of Pediatrics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02708563
    Brief Title
    Meconium Aspiration and Tracheal Suctioning-Feasibility Study
    Acronym
    MATS
    Official Title
    Meconium Aspiration Syndrome and Non-vigorous Neonates-Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Inadequate funds allocated for study completion
    Study Start Date
    July 2019 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Louis University
    Collaborators
    American Academy of Pediatrics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meconium Aspiration Syndrome
    Keywords
    meconium, neonatal resuscitation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate intubation
    Arm Type
    Experimental
    Arm Description
    These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines.
    Arm Title
    Immediate resuscitation
    Arm Type
    Experimental
    Arm Description
    These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning.
    Intervention Type
    Procedure
    Intervention Name(s)
    Immediate intubation
    Intervention Description
    Infants that are not vigorous at delivery will receive immediate tracheal suctioning
    Intervention Type
    Procedure
    Intervention Name(s)
    Immediate resuscitation
    Intervention Description
    Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed
    Primary Outcome Measure Information:
    Title
    Ability to identify, consent, enroll and randomize 70% of eligible infants into study.
    Description
    Feasibility measures
    Time Frame
    18 months
    Title
    The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die
    Description
    Clinical outcome measure
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    5 Minutes
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Meconium Aspiration and Tracheal Suctioning-Feasibility Study

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