Condition: Respiratory Distress of Newborn · Sponsor: Tina Slusher
Breathing problems are a leading cause of newborn death/sickness worldwide but most of deaths are in low resources areas. Over 99% of newborn death is in countries with limited healthcare resources like Nigeria and Nepal. Background For newborns who have trouble breathing, breathing with a machine that does not require an invasive breathing tube but only small nasal tubes is associated with lower rates of lung disease and less pneumonia or lung disease than newborns who have a breathing tube going into their lungs to help their breathing. Nasal Intermittent Positive Pressure Ventilation (NIPPV) is often used in high resource countries, but these machines are expensive. NIPPV gives many newborns the extra support needed to help with trouble breathing by providing extra pressure to help more air/oxygen get into their lungs. Neovent was designed to provide NIPPV at a much lower cost than machines than conventional machines. The Neovent has been shown to be safe and the device feasible in a higher resourced nursery than found in most nurseries in Nigeria and Nepal. The primary and critical research gap this study will address is to show that investigators in lower resourced nurseries can use the Neovent thus demonstrating that this device is feasible to provide NIPPV for newborns with breathing problems without any more safety problems that those seen with the continuous positive airway pressure currently used in lower resourced nurseries in Nigeria and Nepal. Aims The investi…
This description comes directly from the study's public registry record.
Tina M Slusher, MD · 612-840-8883 · tslusher@umn.edu
Ibukun Sonaike, MBBS, MPH · 832-951-0836 · Ibukun.Sonaike@hcmed.org
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| United Mission Hospital-Tansen | Tānsen, Palpa District, Nepal | Not Yet Recruiting |
| Ahmadu Bello University | Zaria, Kano State, Nigeria | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06697951