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Meconium Aspiration and Tracheal Suctioning-Feasibility Study (MATS)

S

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Withdrawn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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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