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The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). The secondary aim is to determine the incidence of pneumothorax (PTX) for all term neonates assessed to have mild respiratory distress in the delivery room (DR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Continuous positive airway pressure (CPAP) is administered for mild respiratory distress |
|
| Watchful waiting | Experimental | Neonates with mild respiratory distress are observed for 20 minutes, and CPAP is administered at 25 minutes of life if respiratory distress continues or earlier if moderate to severe respiratory distress occurs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition without Continuous Positive Airway Pressure (CPAP) | Other | Allowing transition without CPAP administration was assessed at 25 minutes of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for CPAP use at 25 minutes of life | Babies with mild respiratory distress will be observed for 20 minutes (randomized at 5 minutes of life) using a pulse oximeter (per institutional post-resuscitation care guidelines) and under the study team's direct observation. The active cohort will not receive CPAP unless respiratory distress worsens. | At 25 minutes post birth (after 20 minutes of observation) |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of pneumothorax in neonates | Number of babies with pneumothorax in neonates as assessed by a chest ultrasound. | Within 6 hours of life |
| NICU (Neonatal Intensive Care Unit) admission during hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Spillane, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack Univeristy Medical Center | Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| CPAP | Other | CPAP administration as per standard of care |
|
Number of babies admitted to the NICU for respiratory distress during the initial hospital stay (on average, 1-4 days).
| Hospital day (from birth to discharge) |
| D012138 |
| Respiratory Therapy |