Clinical Trial: Meconium Aspiration and Tracheal Suctioning—Feasibility Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Meconium Aspiration Syndrome and Non-vigorous Neonates-Pilot Study

Brief Summary: Feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation.

Detailed Summary: 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.
Sponsor: St. Louis University

Current 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


Original Primary Outcome:

  • Ability to identify, consent, enroll and randomize 70% of eligible infants into study. [ Time Frame: 18 months ]
  • The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die [ Time Frame: 18 months ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Louis University

Dates:
Date Received: March 2, 2016
Date Started: June 2017
Date Completion: September 2018
Last Updated: April 5, 2017
Last Verified: April 2017