Meconium Aspiration and Tracheal Suctioning-Feasibility Study

St. Louis University

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Meconium Aspiration Syndrome

Interventions

Immediate intubationPROCEDURE

Infants that are not vigorous at delivery will receive immediate tracheal suctioning

Immediate resuscitationPROCEDURE

Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed

Eligibility

Sex: ALLMax age: 5 Minutes

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Ability to identify, consent, enroll and randomize 70% of eligible infants into study.

Feasibility measures

Time frame: 18 months

The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die

Clinical outcome measure

Time frame: 18 months

Data from ClinicalTrials.gov

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