Feasibility of Using the Neovent in Low-Resource Settings

NCT06697951 | Recruiting DMC

• 1 other identifier: 2024-821
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

newborn; neonate; respiratory distress; Bilevel ventilation; low resource; Nepal; Nigeria

Outcome Measures

Primary Outcomes (1)

• Feasibility of Using Bubble Nasal Intermittent Pressure Ventilation Using the Neovent in Low-resource Settings

  The investigators will measure the healthcare providers ability in lower-resource nurseries to 1) set up, 2) operate and 3) troubleshoot bubble NIPPV using the Neovent among infants (≤ 28 days) with respiratory distress.

  A physician will confirm the Neovent is set up properly within 1 hour after set up and will also confirm nurses' findings. Hourly fraction of inspired oxygen (FiO2), O2 saturation, respiratory rate, heart rate & Downes' score will be recorded for 6 hrs

Secondary Outcomes (2)

• Healthcare assessment of safety

  Infants will be assessed for clinically significant pneumothorax, septal necrosis, abdominal distention hourly and when the infant changes clinically and study physicians will verify the results are correct for 6 hrs

• Safety of Neovent

  Infants will be assessed for clinically significant pneumothorax, septal necrosis, abdominal distention hourly and when the infant changes clinically and rates for 6 hrs infant in study and will be compared to the those from a higher resourced nursery

Study Arms (1)

single arm

OTHER

Newborns with mild to moderate respiratory distress whose caregivers give permission will be enrolled into the study

Device: bilevel ventilation with the Neovent

Interventions

bilevel ventilation with the Neovent DEVICE

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)

single arm

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tina Slusher: lead

Study Sites (2)

United Mission Hospital-Tansen

Tānsen, Palpa District, Nepal

NOT YET RECRUITING

Ahmadu Bello University

Zaria, Kano State, Nigeria

RECRUITING

Related Publications (12)

• John SC, Garg M, Muttineni M, Brearley AM, Rao P, Bhandari V, Slusher T, Murki S. Safety of bubble nasal intermittent positive pressure ventilation (NIPPV) versus bubble nasal continuous positive airway pressure (NCPAP) in preterm infants with respiratory distress. J Perinatol. 2024 Sep;44(9):1252-1257. doi: 10.1038/s41372-024-01904-8. Epub 2024 Feb 15.

  PMID: 38361002 BACKGROUND

• Tsapis M, Mignot C, Katsahian S, Arbaoui H, Ayachi A. Case-control study of respiratory dynamic compliance in mechanically ventilated near-term newborns in a pre-hospital setting. Intensive Care Med. 2011 Dec;37(12):2008-14. doi: 10.1007/s00134-011-2377-z. Epub 2011 Oct 18.

  PMID: 22005824 BACKGROUND

• John SC, Mohammed A, Church JT, John AV, Perkins EM, McLeod JS, Carr BD, Smith S, Barnett JH, Gustafson PA, Dick M, John SP. Bubble bilevel ventilation facilitates gas exchange in anesthetized rabbits. Pediatr Res. 2021 Feb;89(3):622-627. doi: 10.1038/s41390-020-0928-0. Epub 2020 May 1.

  PMID: 32357365 BACKGROUND

• John SC, John AV, Moss AW, Gustafson PA, Fernando-Silva L, John SP. Bench Testing of a Bubble Noninvasive Ventilation Device in an Infant Lung Simulator. Respir Care. 2020 Sep;65(9):1339-1345. doi: 10.4187/respcare.07346. Epub 2020 Mar 24.

  PMID: 32209707 BACKGROUND

• John SC, Barnett JD, Habben ND, Le HT, Cheng E, John SP, Gustafson PA. Development and Testing of a Bubble Bi-Level Positive Airway Pressure System. Respir Care. 2017 Sep;62(9):1131-1136. doi: 10.4187/respcare.05443. Epub 2017 May 30.

  PMID: 28559463 BACKGROUND

• Martin S, Duke T, Davis P. Efficacy and safety of bubble CPAP in neonatal care in low and middle income countries: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2014 Nov;99(6):F495-504. doi: 10.1136/archdischild-2013-305519. Epub 2014 Aug 1.

  PMID: 25085942 BACKGROUND

• Lemyre B, Davis PG, de Paoli AG. Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) for apnea of prematurity. Cochrane Database Syst Rev. 2002;(1):CD002272. doi: 10.1002/14651858.CD002272.

  PMID: 11869635 BACKGROUND

• Lemyre B, Davis PG, De Paoli AG, Kirpalani H. Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) for preterm neonates after extubation. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD003212. doi: 10.1002/14651858.CD003212.pub3.

  PMID: 28146296 BACKGROUND

• Lemyre B, Laughon M, Bose C, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD005384. doi: 10.1002/14651858.CD005384.pub2.

  PMID: 27976361 BACKGROUND

• Bhandari V. Nasal intermittent positive pressure ventilation in the newborn: review of literature and evidence-based guidelines. J Perinatol. 2010 Aug;30(8):505-12. doi: 10.1038/jp.2009.165. Epub 2009 Oct 22.

  PMID: 19847188 BACKGROUND

• Schonherr U, Kuchle M, Handel A, Lang GK, Kuntze H, Naumann GO. ["Early" immunologic transplant reactions following perforating keratoplasty. A prospective clinical study]. Fortschr Ophthalmol. 1990;87(2):121-3. German.

  PMID: 2358265 BACKGROUND

• Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.

  PMID: 15752534 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tina M Slusher, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

• Isa Abulkadir, MBBS

  Ahmadu Bellow University

  PRINCIPAL INVESTIGATOR

• Sunil John, MD

  United Mission Hospital-Tansen, Nepal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina M Slusher, MD

CONTACT

612-840-8883; tslusher@umn.edu

Ibukun Sonaike, MBBS, MPH

CONTACT

832-951-0836; Ibukun.Sonaike@hcmed.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not possible to mask and not required for this study
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: This is a study to test the usability of a low-cost way to do Non-invasive Positive Pressure Ventilation using the Neovent a device in lower resourced nurseries, Neovent has already be shown to be feasible in a higher resourced setting outside the United States in newborn infants with mild to moderate respiratory distress. The study plans to use the Neovent in lower-resourced nurseries who have respiratory distress in Nigeria and Nepal whose mothers give consent. The Neovent has been approved by regulatory bodies in India where the device is being manufactured for low-resource settings and will only be used for this study in Nigeria and Nepal and thus does not fall under FDA regulation. No patients will be enrolled from the United States therefore this study will not collect data for the purpose of approval for use in the United States.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 20, 2024
• Study Start: March 10, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-03

Locations

NG (1); NE (1)