Feasibility of Using the Neovent in Low-Resource Settings

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 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 investigators believe NIPPV using the Neovent is feasible for use by healthcare providers in lower resourced nurseries in Nepal and Nigeria; that NIPPV provided by Neovent will be as safe as breathing support providing by machine CPAP and newborns on Neovent will not have more nasal irritation or nose bleeds, more stomach problems, or air around their lungs than newborns on machine CPAP.

Study design Newborns with mild-moderate breathing trouble whose mother/caregivers agrees will be placed on Neovent for 6 hours and monitored closely for any problems with the machine or newborn that are related to the machine especially injury to the nose, nosebleeds, swollen belly or abdomen, or air around the lungs.

Sample size We plan to enroll 70 newborn infants total from both sites in Nepal and Nigeria.

Next Steps The next step would be to do a study to determine if the Neovent is as good as other more expensive forms of breathing support for newborn infants.

Conditions

• Respiratory Distress of Newborn

Interventions

DEVICE

bilevel ventilation with the Neovent

Newborn infants with respiratory distress will be placed on the Neovent and we will see if study staff set up, use, and trouble shoot the Neovent correctly and see if study staff can monitor for safety problems in lower-resourced nurseries and to determine if the infants have any more problems than seen with bubble CPAP or Neovent in a higher resourced nursery including any more nasal irritation, abdominal distention, or clinically important amount of air around the lung (pneumothorax)

Sponsors & Collaborators

• Tina Slusher

  lead OTHER

Principal Investigators

• Tina M Slusher, MD · Hennepin Healthcare Research Institute

• Isa Abulkadir, MBBS · Ahmadu Bellow University

• Sunil John, MD · United Mission Hospital-Tansen, Nepal

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Minute

Max Age

28 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-10

Primary Completion

2025-10-30

Completion

2025-12-31

Countries

• Nepal
• Nigeria

Study Locations