Neovent bilevel ventilation for newborns in low-resource hospitals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ahmadu Bello University
  Zaria, Kano State, Nigeria Recruiting
• United Mission Hospital-Tansen
  Tānsen, Palpa District, Nepal Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.