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NCT03109613
PEEP and V/Q Mismatch in Premature Infants
Phase 1, PHASE2 trial testing Positive end-expiratory pressure (PEEP) in Respiratory Insufficiency Syndrome of Newborn in 12 participants. Terminated before completion.
8 August 2018
Quick facts
| Lead sponsor | Children's Hospital of Philadelphia |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 11 April 2016 |
| Primary completion | 8 August 2018 |
| Estimated completion | 8 August 2018 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Positive end-expiratory pressure (PEEP)
Conditions studied
- Respiratory Insufficiency Syndrome of Newborn — all drugs for Respiratory Insufficiency Syndrome of Newborn →
- Infant, Premature, Diseases — all drugs for Infant, Premature, Diseases →
Sponsor
Children's Hospital of Philadelphia
Who can join
Adults 0 Days to 28 Days, any sex, with Respiratory Insufficiency Syndrome of Newborn or Infant, Premature, Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03109613
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03109613 (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 Children's Hospital of Philadelphia
- Last refreshed: 17 November 2020
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/NCT03109613.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing