Meconium Aspiration and Tracheal Suctioning-Feasibility Study (MATS)

Saint Louis University (SLU)

Status: Withdrawn

Conditions: Meconium Aspiration Syndrome

Treatments: Procedure: Immediate resuscitation; Procedure: Immediate intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT02708563

SLU-19817

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: Under 5 minutes old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Immediate intubation

Experimental group

Description:

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

Treatment:

Procedure: Immediate intubation

Immediate resuscitation

Experimental group

Description:

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

Treatment:

Procedure: Immediate resuscitation