Neovent bilevel ventilation for newborns in low-resource hospitals
Feasibility of Using Bubble Nasal Intermittent Pressure Ventilation Using the Neovent in Low-resource Settings
This project will test whether the Neovent, a low-cost bilevel breathing support device, helps newborns with mild to moderate respiratory distress in low-resource hospitals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 1 Minute to 28 Days |
| Sex | All |
| Sponsor | Hennepin Healthcare Research Institute Academic / other |
| Locations | 2 sites (Tānsen, Palpa District and 1 other locations) |
| Trial ID | NCT06697951 on ClinicalTrials.gov |
What this trial studies
The trial uses the Neovent to deliver nasal intermittent positive pressure ventilation (NIPPV) to newborns with mild to moderate respiratory distress, aiming to show the device is safe and workable in low-resource settings. Eligible infants are ≤28 days old and either >30 weeks gestation or >1000 g weight, with a Downes' score of 2–7, and require parental consent. The intervention is noninvasive bilevel ventilation via nasal prongs at participating hospitals in Nepal and Nigeria, with outcomes focused on feasibility, safety, and need for escalation to invasive ventilation. The Neovent was designed to provide NIPPV at much lower cost than conventional machines and prior small evaluations have suggested it is feasible and safe.
Who should consider this trial
Good fit: Newborns up to 28 days old who are >30 weeks gestation or >1000 g, with mild-to-moderate respiratory distress (Downes' score 2–7) whose parents consent are ideal candidates.
Not a fit: Infants with severe life-threatening conditions, congenital abnormalities that contraindicate noninvasive ventilation, suspected cyanotic cardiac disease or neuromuscular weakness, or those needing immediate surgery are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could reduce the need for invasive breathing tubes and lower complications and deaths from neonatal respiratory distress in low-resource hospitals.
How similar studies have performed: NIPPV is established in higher-resource settings and reduces the need for intubation, while the low-cost Neovent has limited prior feasibility and safety data and is relatively novel in low-resource hospitals.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tānsen, Palpa District and 1 other locations
- United Mission Hospital-Tansen — Tānsen, Palpa District, Nepal (Not_yet_recruiting)
- Ahmadu Bello University — Zaria, Kano State, Nigeria (Recruiting)
Study contacts
- Principal investigator: Tina M Slusher, MD — Hennepin Healthcare Research Institute
- Study coordinator: Tina M Slusher, MD
- Email: tslusher@umn.edu
- Phone: 612-840-8883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.