Feasibility of Using the Neovent in Low-Resource Settings
ConditionRespiratory Distress of Newborn
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorTina Slusher
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
bilevel ventilation with the Neovent
DeviceNewborn 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)
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: single armOther 1 intervention
Trial outcomes
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.
Time frame
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 hrsSecondary outcomes
1
Healthcare assessment of safety
The investigators will safety including the healthcare providers correct evaluation/staging of nasal septal injury, nosebleeds, abdominal distention, clinically significant pneumothorax and verify that the healthcares assessment is correct
Time frame
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 hrs2
Safety of Neovent
Rates of clinically significant pneumothorax, nasal septal injury, nose bleeds, abdominal distention) will be measured and compared to those previously seen in between bubble NIPPV using the Neovent in lower resourced nurseries and those seen previously with bubble CPAP and Neovent in a higher resourced nursery
Time frame
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 nurserySponsors and contacts
Click on the lead sponsor to view all of their trials.
Tina Slusher
Lead sponsor
Hennepin Healthcare Research Institute
Sponsor institution
Source ClinicalTrials.gov