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| Name | Class |
|---|---|
| American Academy of Pediatrics | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate intubation | Experimental | These infants will have immediate endotracheal suctioning after delivery. They will then have resuscitation per Neonatal Resuscitation Program guidelines. |
|
| Immediate resuscitation | Experimental | These infants will have immediate resuscitation per the Neonatal Resuscitation Program guidelines without endotracheal suctioning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate intubation | Procedure | Infants that are not vigorous at delivery will receive immediate tracheal suctioning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to identify, consent, enroll and randomize 70% of eligible infants into study. | Feasibility measures | 18 months |
| The number of infants in the study who develop meconium aspiration syndrome, require extracorporeal membrane oxygenation or die | Clinical outcome measure | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008471 | Meconium Aspiration Syndrome |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Immediate resuscitation | Procedure | Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed |
|
| D005315 |
| Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |