Feasibility of Using the Neovent in Low-Resource Settings
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
| Condition(s) | Respiratory Distress of Newborn |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * Infants ≤ 28 days and \> 30weeks and/or \> 1000 gram (birthweight or admission weight if birthweight unknown) * Mild to moderate respiratory distress (Downes' score 2 - 7) * Parental/guardian permission (informed consent). Exclusion Criteria: * Congenital abnormality such that noninvasive positive pressure ventilation would be contraindicated (e.g. diaphragmatic hernia, cleft palate, tracheo-esophageal fistula) * Need for immediate surgical intervention * Suspected neuromuscular abnormality as evidenced by decreased tone * Suspected cyanotic congenital cardiac disease or cardiac instability * Severe life-threatening condition such that the doctor caring for the patient believes survival of patient will be less than 24 hours and/or parents request withdrawal of care |
| Ages | 1 Minute to 28 Days |
| Sex | All |
| Lead sponsor | Tina Slusher |
| Locations | Tānsen, Palpa District, Nepal; Zaria, Kano State, Nigeria |
| Start date | 2025-03-10 |
| NCT ID | NCT06697951 |
| Official listing | https://clinicaltrials.gov/study/NCT06697951 |