Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room
1 other identifier
interventional
100
1 country
2
Brief Summary
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2020
CompletedStudy Start
First participant enrolled
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedFebruary 24, 2020
February 1, 2020
6 months
February 17, 2020
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Silverman Score
The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.
6 months
Secondary Outcomes (1)
N-PASS score
6 months
Study Arms (4)
HHFNC
ACTIVE COMPARATORIn this group patients will receive respiratory support by high flow nasal cannula.
nCPAP
ACTIVE COMPARATORIn this group patients will receive respiratory support by nasal CPAP.
nIPPV
ACTIVE COMPARATORIn this group patients will receive respiratory support by nasal IPPV.
nHFO
ACTIVE COMPARATORIn this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation.
Interventions
Eligibility Criteria
You may qualify if:
- late preterm and term infants with respiratory distress
You may not qualify if:
- intubation for the respiratory distres.
- major abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kanuni Sultan Suleyman Research and Training Hospital
Istanbul, 34065, Turkey (Türkiye)
Kanuni Sultan Suleyman Research and Training Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neonatologist
Study Record Dates
First Submitted
February 17, 2020
First Posted
February 24, 2020
Study Start
February 18, 2020
Primary Completion
August 1, 2020
Study Completion
December 15, 2020
Last Updated
February 24, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share