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NCT05961683
Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software
NA trial testing NIV plus software in Respiratory Distress Syndrome, Newborn in 100 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | Keck School of Medicine of USC |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 August 2023 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NIV plus software
Conditions studied
- Respiratory Distress Syndrome, Newborn — all drugs for Respiratory Distress Syndrome, Newborn →
- Apnea of Newborn — all drugs for Apnea of Newborn →
Sponsor
Keck School of Medicine of USC
Who can join
Adults 0 Days to 30 Days, any sex, with Respiratory Distress Syndrome, Newborn or Apnea of Newborn. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In the past many neonates with respiratory distress syndrome would require intubation, but over the years these rates have declined as the capabilities of non-invasive ventilation (NIV) have vastly improved. Despite these improvements, the decrease in pressure transmission due to factors such as resistance from tubing or air leaks around the nostrils and mouth, continues to be one of the major drawbacks when using nasal NIV. Current ventilators measure the set pressures at the circuit but do not capture the delivered pressure at the patient's nares. Recently, Medtronic PB980 ventilators feature NIV plus and leak sync software that can be calibrated to measure the pressures provided at the nostrils. Optimum pressures received at the nostrils to provide safe and effective therapy in neonates is currently unknown. In the prospective portion of the study, we aim to evaluate safety and efficacy of the software by comparing the average pressure difference between the circuit and delivery pressure at the nares, the incidence of apnea, bradycardia, desaturations as well as escalation and de-escalation of ventilator support in newborns who are receiving NIV admitted to NICU
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05961683
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Related trials
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Currently open trials in the same condition.
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- NCT06007547 — Prophylactic Minimally Invasive Surfactant Evaluation · Phase 4 · recruiting
Other Keck School of Medicine of USC trials
Trials by the same sponsor.
- NCT07219862 — Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization · NA · not yet recruiting
- NCT06351215 — PO Methadone Ortho Outpatient · Phase 3 · not yet recruiting
- NCT05961670 — Application of Lung Near-Infrared Spectroscopy (NIRS) in Preterm Infants · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05961683 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Keck School of Medicine of USC
- Last refreshed: 27 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05961683.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing