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| Name | Class |
|---|---|
| Haydom Lutheran Hospital | OTHER |
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Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Animal studies suggest that assisted ventilation with positive end expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid recovery. However, no large human clinical studies have investigated the clinical responses to assisted ventilation with PEEP in asphyxiated newborns.
Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical beneficial outcomes remains to be proven.
The aim is to study whether lung aeration can be improved by adding a device for positive end expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upright Resuscitator with PEEP | Experimental | Ventilation with the Upright Resuscitator with PEEP |
|
| Upright Resuscitator | Active Comparator | Ventilation with the Upright Resuscitator (without PEEP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upright Resuscitator with PEEP | Device |
| ||
| Upright Resuscitator |
| Measure | Description | Time Frame |
|---|---|---|
| Delta heart rate (beats/minute) during each ventilation sequence | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal outcome dead versus alive | Up to 24 hours | |
| Time to cessation of ventilation | Up to 1 hour | |
| Time to heart rate above 140 beats/minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hussein Kidanto, MD, PhD | Muhimibili National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haydom Lutheran Hospital, Research Institute | Haydom | Manyara Region | 9041 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32917847 | Derived | Holte K, Ersdal H, Eilevstjonn J, Gomo O, Klingenberg C, Thallinger M, Linde J, Stigum H, Yeconia A, Kidanto H, Stordal K. Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial. Pediatrics. 2020 Oct;146(4):e20200494. doi: 10.1542/peds.2020-0494. Epub 2020 Sep 11. |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Device |
|
| Up to 1 hour |
| Mean ariway pressures given | Up to 1 hour |
| Time to detection of exhaled CO2 above 1% and 4% | Up to 1 hour |