Meconium Aspiration and Tracheal Suctioning-Feasibility Study

Not Applicable

Withdrawn

• Conditions: Meconium Aspiration Syndrome
• Interventions: Procedure: Immediate resuscitation; Procedure: Immediate intubation

• Registration Number: NCT02708563
• Lead Sponsor: St. Louis University

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.

Study Timeline

• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-15
• Status Verified: 2019-07
• Study Start: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31
• Primary Completion: 2020-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate resuscitation	Immediate resuscitation	These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning.
Immediate intubation	Immediate intubation	These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines.

Primary Outcome Measures

Name	Time	Method
Ability to identify, consent, enroll and randomize 70% of eligible infants into study.	18 months	Feasibility measures
The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die	18 months	Clinical outcome measure