Meconium Aspiration Syndrome
Conditions
Keywords
meconium, neonatal resuscitation
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.
Interventions
PROCEDUREImmediate intubation
Infants that are not vigorous at delivery will receive immediate tracheal suctioning
PROCEDUREImmediate resuscitation
Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed
Sponsors
American Academy of Pediatrics
St. Louis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Minutes
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed