Feasibility of Using the Neovent in Low-Resource Settings
NCT ID: NCT06697951
Last Updated: 2025-06-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-03-10
Study Completion Date
2025-12-31
Brief Summary
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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.
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.
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Detailed Description
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BACKGROUND INFORMATION AND RATIONALE Infant respiratory distress is a leading cause of under-5 mortality worldwide, resulting in over one million infant deaths every year. Over 99% of these deaths occur in low to middle income countries For these vulnerable infants, noninvasive ventilation is preferred as it is associated with lower rates of chronic lung disease and ventilator-associated-pneumonia than invasive modes of ventilation. Widely used methods of noninvasive respiratory support for infants in respiratory distress include Nasal Continuous Positive Airway Pressure (NCPAP) and Nasal Intermittent Positive Pressure Ventilation (NIPPV). NCPAP consists of delivering a constant pressure, typically from 5 - 8 cm H2O, to recruit and stabilize the alveoli and improve ventilation and perfusion mismatch. NIPPV provides additional respiratory support with intermittent mandatory ventilation over the constant baseline pressure, e.g. 15 cm H2O over 5 cm H2O. The lower pressure is termed "P low" and the higher pressure is termed "P high". This additional respiratory support reduces the work of breathing3. In comparison with NCPAP, NIPPV has been shown to decrease the need for ventilation of preterm infants, decrease post-extubation failure and may further decrease the frequency of apneic episodes.
Bubble NCPAP is a simple, non-electric and easy to use means of delivering CPAP that has been successfully implemented across low and high resource settings 7,8. Unfortunately, until the present, there has not been an analogous simple, non-electric and easy to use means to deliver NIPPV. Conventional NIPPV equipment costs $10,000+, requires continuous electricity and requires many highly trained operators (physician, respiratory therapist, biomedical equipment technician), all of which serve as barriers to implementation in resource- constrained settings.
To address these barriers, a novel bubble NIPPV device, NeoVent, has been developed and shown to be both feasible and safe in a higher resourced nursery. With NeoVent, clinicians can independently set key parameters: upper level of pressure, lower level of pressure and rate (cycles/min). The technology is non-electric and visually intuitive to set up and operate. In the ASL 6000 infant lung simulator, NeoVent delivered comparable volumes and pressure waveforms as conventional ventilators. In sedated rabbits, NeoVent was able to achieve comparable ventilation, as demonstrated by arterial blood gas values, as a conventional ventilator13. In a first-in-human study of safety, NeoVent achieved a similar safety profile to bubble NCPAP 14. In a larger follow on study of safety, NeoVent again achieved a similar safety profile as bubble CPAP. Results have been published/presented in peer-reviewed forums including Pediatric Research, Respiratory Care, American Academy of Pediatrics, Indian Academy of Pediatrics, Canadian Society of Respiratory Therapists, Medicins Sans Frontieres and USAID/Gates Foundation's Grand Challenges in Global Health.
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.
Primary Aim: Among infants (≤ 28 days) with respiratory distress settings, bubble NIPPV using the Neovent is feasible for use by healthcare providers in lower resourced nurseries in Nigeria and Nepal. This will test the hypothesis that at least 80% of healthcare providers' (clinicians/nurses) in lower resourced nurseries in Nigeria and Nepal can 1) set up, 2) operate and 3) troubleshoot bubble NIPPV using the Neovent and will be qualitatively assessed 3 months after introduction of the NIPPV in their NICU-based on survey/questionnaire/and demonstration.
Secondary Aims
* To demonstrate that health care providers in lower resourced nurseries in Nigeria and Nepal will be able evaluate for safety and correctly evaluate/stage nasal septal injury, nosebleeds, abdominal distention, clinically significant pneumothorax. This will test the hypothesis that healthcare providers in lower-resourced nurseries can correctly access for the primary safety concerns expected when using the Neovent.
* To demonstrate comparable rates of short-term complications (pneumothorax, nasal septal injury, nose bleeds, abdominal distention) between bubble NIPPV and those seen in previously with bubble CPAP. This will test the hypothesis that the side effects rates arse comparable in lower resourced nurseries to those seen both with bubble CPAP and with the Neovent in a higher resourced nurseries
Design: Over 6 months, 60 infants (≤28 days) and (≥30 weeks GA or ≥1000 grams if GA unknown) in mild to moderate respiratory distress in resource constrained referral hospitals in Nigeria and Nepal will be placed on bubble NIPPV with a Downes Score of 2-7. Health care providers (nurses together with physicians) ability to set up, operate and troubleshoot bubble NIPPV including monitoring for safety evaluating for nasal septal injury, abdominal distention and clinically significant pneumothorax will be qualitatively assessed.
Potential Impact: If bubble NIPPV is shown to be feasible and safe in resource constrained settings, this will justify further randomized controlled trials of efficacy.
Name and Description of Investigational Product or Intervention NeoVent delivers bubble Nasal Intermittent Positive Pressure Ventilation and is manufactured by Phoenix Medical Systems.
* 1 minute video describing device function: https://www.youtube.com/watch?v=cYZwbZK7lW4
* Product Description: https://www.phoenixmedicalsystems.com/infant-care/neovent Findings from Non-Clinical and Clinical Studies Pre-clinical studies In full-term and preterm neonatal manikins, bubble NIPPV reliably delivered alternating pressures consistent with standard NIPPV equipment9,10. In the IngMar ASL 5000 Test Lung simulator, delivered pressure waveforms and tidal volumes of bubble NIPPV were comparable with those of 2 conventional ventilators (Dräger Evita Infinity V500 and Hamilton G5) at the following pressure settings: 8/5, 12/5, and 15/5 cm H2O11,12. To simulate patients with pneumonia, transient tachypnea of the newborn and meconium aspiration syndrome, lung resistance was set at 100 cm H2O/L/s, and compliance set at 0.5, 1.0, and 2.0 mL/cm H2O15.
In anesthetized rabbits, bubble NIPPV reliably delivered two levels of airway pressure resulting in normalization of blood gases comparable to those achieved on a traditional ventilator13.
The delivery of comparable pressure waveforms and tidal volumes in lung simulators and normalization of arterial blood gas values in sedated animals suggests that bubble NIPPV provides treatment which may be comparable to traditional ventilator derived NIPPV. Thus, bubble NIPPV may provide clinicians in resource-limited settings with an additional, simple, non-electric treatment modality for the management of infant respiratory distress beyond bubble NCPAP alone.
Clinical studies Pilot data in a single center in Nepal In a cross-over cohort pilot in Nepal, 7 infants with moderate respiratory distress were randomized to 4 hours of treatment with bubble NCPAP vs bubble NIPPV followed by 4 hours of the alternate treatment. Vital signs, Downes' score (Retractions, Cyanosis, Respiratory Rate, Apnea, Expiratory Grunt) and O2 saturations were charted hourly. Survival and adverse events such as pneumothorax, nasal septal necrosis, necrotizing enterocolitis were recorded. All infants survived with similar median and interquartile values of vitals and Downes' scores, with no adverse events.
Safety in a single center in India At Paramitha Children's Hospital, a higher resourced nursery in Hyderabad, India, preterm (n=60) neonates with moderate respiratory distress were pragmatically allocated to bubble NCPAP (5-8 cm H2O) or bubble NIPPV (P high 8-10 cm H2O /P low 5-8 cm H2O) based on staff and equipment availability. Patient demographics on NCPAP and NIPPV were similar (mean +- SD; gestational age: 34.5 (1.4) vs. 34.6 (1.1) weeks; birth weight 2.2 (0.5) vs. 2.3 (0.4) kg; male: 67% vs. 67%) except for initial Respiratory Severity Score (RSS) which was 1.4 (0.4) on NCPAP vs. 2.4 (1.5) on NIPPV (p = .0008). Outcome measures included physiologic outcomes (hourly vital signs, Downes' score, FiO2), need for surfactant and need for intubation as well as complications including clinically relevant pneumothorax, septal necrosis, abdominal distention and other common complications of prematurity.
One patient in each arm developed minor nasal septal injury (grade 3 on NCPAP, grade 2 on NIPPV); no patients in either arm developed a clinically significant pneumothorax or abdominal distention. On NCPAP vs. NIPPV, 4 vs. 3 patients required a 1st dose of surfactant (excluding doses within the first two hours), and 1 vs. 0 patients required a second dose of surfactant. Two patients in the NCPAP arm required intubation in comparison with 4 patients in the NIPPV arm. There was a clinically and statistically significant improvement in FiO2 and Downes' score in NIPPV in comparison with NCPAP although patients on NIPPV did start with increased respiratory distress.
The similar rates of clinically significant nasal septal injury, pneumothorax and abdominal distention suggest that bubble NIPPV has a similar safety profile as bubble NCPAP for preterm infants in respiratory distress. Randomized controlled trials comparing the efficacy of bubble NCPAP and bubble NIPPV are warranted.
Given the demonstrated safety at one mid-resourced referral hospital, the investigators seek to study feasibility followed by efficacy in resource constrained hospitals.
Reference omitted but available upon request
Bubble NCPAP is a simple, non-electric and easy to use means of delivering CPAP that has been successfully implemented across low and high resource settings 7,8. Unfortunately, until the present, there has not been an analogous simple, non-electric and easy to use means to deliver NIPPV. Conventional NIPPV equipment costs $10,000+, requires continuous electricity and requires many highly trained operators (physician, respiratory therapist, biomedical equipment technician), all of which serve as barriers to implementation in resource- constrained settings.
To address these barriers, a novel bubble NIPPV device, NeoVent, has been developed and shown to be both feasible and safe in a higher resourced nursery. With NeoVent, clinicians can independently set key parameters: upper level of pressure, lower level of pressure and rate (cycles/min). The technology is non-electric and visually intuitive to set up and operate. In the ASL 6000 infant lung simulator, NeoVent delivered comparable volumes and pressure waveforms as conventional ventilators. In sedated rabbits, NeoVent was able to achieve comparable ventilation, as demonstrated by arterial blood gas values, as a conventional ventilator13. In a first-in-human study of safety, NeoVent achieved a similar safety profile to bubble NCPAP 14. In a larger follow on study of safety, NeoVent again achieved a similar safety profile as bubble CPAP. Results have been published/presented in peer-reviewed forums including Pediatric Research, Respiratory Care, American Academy of Pediatrics, Indian Academy of Pediatrics, Canadian Society of Respiratory Therapists, Medicins Sans Frontieres and USAID/Gates Foundation's Grand Challenges in Global Health.
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.
Primary Aim: Among infants (≤ 28 days) with respiratory distress settings, bubble NIPPV using the Neovent is feasible for use by healthcare providers in lower resourced nurseries in Nigeria and Nepal. This will test the hypothesis that at least 80% of healthcare providers' (clinicians/nurses) in lower resourced nurseries in Nigeria and Nepal can 1) set up, 2) operate and 3) troubleshoot bubble NIPPV using the Neovent and will be qualitatively assessed 3 months after introduction of the NIPPV in their NICU-based on survey/questionnaire/and demonstration.
Secondary Aims
* To demonstrate that health care providers in lower resourced nurseries in Nigeria and Nepal will be able evaluate for safety and correctly evaluate/stage nasal septal injury, nosebleeds, abdominal distention, clinically significant pneumothorax. This will test the hypothesis that healthcare providers in lower-resourced nurseries can correctly access for the primary safety concerns expected when using the Neovent.
* To demonstrate comparable rates of short-term complications (pneumothorax, nasal septal injury, nose bleeds, abdominal distention) between bubble NIPPV and those seen in previously with bubble CPAP. This will test the hypothesis that the side effects rates arse comparable in lower resourced nurseries to those seen both with bubble CPAP and with the Neovent in a higher resourced nurseries
Design: Over 6 months, 60 infants (≤28 days) and (≥30 weeks GA or ≥1000 grams if GA unknown) in mild to moderate respiratory distress in resource constrained referral hospitals in Nigeria and Nepal will be placed on bubble NIPPV with a Downes Score of 2-7. Health care providers (nurses together with physicians) ability to set up, operate and troubleshoot bubble NIPPV including monitoring for safety evaluating for nasal septal injury, abdominal distention and clinically significant pneumothorax will be qualitatively assessed.
Potential Impact: If bubble NIPPV is shown to be feasible and safe in resource constrained settings, this will justify further randomized controlled trials of efficacy.
Name and Description of Investigational Product or Intervention NeoVent delivers bubble Nasal Intermittent Positive Pressure Ventilation and is manufactured by Phoenix Medical Systems.
* 1 minute video describing device function: https://www.youtube.com/watch?v=cYZwbZK7lW4
* Product Description: https://www.phoenixmedicalsystems.com/infant-care/neovent Findings from Non-Clinical and Clinical Studies Pre-clinical studies In full-term and preterm neonatal manikins, bubble NIPPV reliably delivered alternating pressures consistent with standard NIPPV equipment9,10. In the IngMar ASL 5000 Test Lung simulator, delivered pressure waveforms and tidal volumes of bubble NIPPV were comparable with those of 2 conventional ventilators (Dräger Evita Infinity V500 and Hamilton G5) at the following pressure settings: 8/5, 12/5, and 15/5 cm H2O11,12. To simulate patients with pneumonia, transient tachypnea of the newborn and meconium aspiration syndrome, lung resistance was set at 100 cm H2O/L/s, and compliance set at 0.5, 1.0, and 2.0 mL/cm H2O15.
In anesthetized rabbits, bubble NIPPV reliably delivered two levels of airway pressure resulting in normalization of blood gases comparable to those achieved on a traditional ventilator13.
The delivery of comparable pressure waveforms and tidal volumes in lung simulators and normalization of arterial blood gas values in sedated animals suggests that bubble NIPPV provides treatment which may be comparable to traditional ventilator derived NIPPV. Thus, bubble NIPPV may provide clinicians in resource-limited settings with an additional, simple, non-electric treatment modality for the management of infant respiratory distress beyond bubble NCPAP alone.
Clinical studies Pilot data in a single center in Nepal In a cross-over cohort pilot in Nepal, 7 infants with moderate respiratory distress were randomized to 4 hours of treatment with bubble NCPAP vs bubble NIPPV followed by 4 hours of the alternate treatment. Vital signs, Downes' score (Retractions, Cyanosis, Respiratory Rate, Apnea, Expiratory Grunt) and O2 saturations were charted hourly. Survival and adverse events such as pneumothorax, nasal septal necrosis, necrotizing enterocolitis were recorded. All infants survived with similar median and interquartile values of vitals and Downes' scores, with no adverse events.
Safety in a single center in India At Paramitha Children's Hospital, a higher resourced nursery in Hyderabad, India, preterm (n=60) neonates with moderate respiratory distress were pragmatically allocated to bubble NCPAP (5-8 cm H2O) or bubble NIPPV (P high 8-10 cm H2O /P low 5-8 cm H2O) based on staff and equipment availability. Patient demographics on NCPAP and NIPPV were similar (mean +- SD; gestational age: 34.5 (1.4) vs. 34.6 (1.1) weeks; birth weight 2.2 (0.5) vs. 2.3 (0.4) kg; male: 67% vs. 67%) except for initial Respiratory Severity Score (RSS) which was 1.4 (0.4) on NCPAP vs. 2.4 (1.5) on NIPPV (p = .0008). Outcome measures included physiologic outcomes (hourly vital signs, Downes' score, FiO2), need for surfactant and need for intubation as well as complications including clinically relevant pneumothorax, septal necrosis, abdominal distention and other common complications of prematurity.
One patient in each arm developed minor nasal septal injury (grade 3 on NCPAP, grade 2 on NIPPV); no patients in either arm developed a clinically significant pneumothorax or abdominal distention. On NCPAP vs. NIPPV, 4 vs. 3 patients required a 1st dose of surfactant (excluding doses within the first two hours), and 1 vs. 0 patients required a second dose of surfactant. Two patients in the NCPAP arm required intubation in comparison with 4 patients in the NIPPV arm. There was a clinically and statistically significant improvement in FiO2 and Downes' score in NIPPV in comparison with NCPAP although patients on NIPPV did start with increased respiratory distress.
The similar rates of clinically significant nasal septal injury, pneumothorax and abdominal distention suggest that bubble NIPPV has a similar safety profile as bubble NCPAP for preterm infants in respiratory distress. Randomized controlled trials comparing the efficacy of bubble NCPAP and bubble NIPPV are warranted.
Given the demonstrated safety at one mid-resourced referral hospital, the investigators seek to study feasibility followed by efficacy in resource constrained hospitals.
Reference omitted but available upon request
Conditions
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Respiratory Distress of Newborn
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
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.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Not possible to mask and not required for this study
Study Groups
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single arm
Newborns with mild to moderate respiratory distress whose caregivers give permission will be enrolled into the study
Group Type
OTHER
bilevel ventilation with the Neovent
Intervention Type
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)
Interventions
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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)
Intervention Type
DEVICE
Eligibility Criteria
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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).
* 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
* 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
Minimum Eligible Age
1 Minute
Maximum Eligible Age
28 Days
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Tina Slusher
OTHER
Sponsor Role
lead
Responsible Party
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Tina Slusher
MD
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Tina M Slusher, MD
Role: PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute
Isa Abulkadir, MBBS
Role: PRINCIPAL_INVESTIGATOR
Ahmadu Bellow University
Sunil John, MD
Role: PRINCIPAL_INVESTIGATOR
United Mission Hospital-Tansen, Nepal
Locations
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United Mission Hospital-Tansen
Tānsen, Palpa District, Nepal
Site Status
NOT_YET_RECRUITING
Ahmadu Bello University
Zaria, Kano State, Nigeria
Site Status
RECRUITING
Countries
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Nepal
Nigeria
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
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2024-821
Identifier Type: -
Identifier Source: org_study_id
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Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants
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COMPLETED
NA
High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
NCT01270581
TERMINATED
NA
Integrated Prediction of Extubation Outcome by the Spontaneous Breathing Trial in Newborn Infants
NCT03956511
COMPLETED
Comparison of Humidified High Flow Nasal Cannula to Nasal CPAP in Neonates
NCT00609882
COMPLETED
NA
Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation
NCT02543125
UNKNOWN
NA
Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms
NCT02396693
COMPLETED
NA
Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe
NCT03510169
UNKNOWN
NA
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
NCT04905732
UNKNOWN
NA
nHFOV Versus nCPAP in Transient Tachypnea of the Newborn
NCT03006354
COMPLETED
NA
Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants
NCT03137225
TERMINATED
NA
Effect of Establishing Functional Residual Capacity During Newborn Resuscitation on Oxygenation
NCT00531102
TERMINATED
NA
Work of Breathing During Non-invasive Ventilation in Premature Neonates
NCT02788110
COMPLETED
NA
Validation of a Novel Oxygen Consumption Measurement Technique in Neonates
NCT03154112
COMPLETED
Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room
NCT03938532
TERMINATED
NA
Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
NCT02340299
TERMINATED
NA
Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates
NCT05592431
COMPLETED
NA
Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung Ultrasound
NCT06550219
RECRUITING
NA
Airway Pressure During Nasal High Flow and CPAP in Neonates
NCT02632799
COMPLETED
NA
Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP
NCT01939067
WITHDRAWN
PHASE1
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
NCT05706428
COMPLETED
NA
nHFOV vs nCPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From RDS
NCT02772835
COMPLETED
NA
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
NCT06295484
RECRUITING
NA
Delivery Room CPAP in Extremely Low Birth Weight Infants
NCT01223274
COMPLETED
PHASE1/PHASE2