NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation
Nasal Intermittent Positive Pressure Ventilation Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation in Infants ≤ 1250 g Birthweight
1 other identifier
interventional
140
1 country
1
Brief Summary
Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants. Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following extubation in preterm infants ≤ 1250 g birthweight.
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 Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2016
CompletedFirst Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2019
CompletedOctober 4, 2019
October 1, 2019
1.5 years
July 20, 2016
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of extubation failure
within 96 hours
Study Arms (2)
NIPPV
ACTIVE COMPARATORNIPPV after ekstubation
BIPAP
NO INTERVENTIONBIPAP after ekstubation
Interventions
Eligibility Criteria
You may qualify if:
- Mechanically ventilated preterm infants with birthweight ≤1250 g
You may not qualify if:
- Infants with major congenital malformations, neuromuscular disease and lack of parental consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zekai Tahir Burak Maternity Teaching hospital
Ankara, Turkey (Türkiye)
Related Publications (1)
Okur N, Buyuktiryaki M, Sari FN, Dizdar EA, Oguz SS. Ventilator-delivered nasal intermittent positive pressure ventilation versus nasal biphasic positive airway pressure following extubation in infants </=1250 g birth weight: a randomized trial. J Matern Fetal Neonatal Med. 2022 Feb;35(4):752-758. doi: 10.1080/14767058.2020.1731462. Epub 2020 Feb 27.
PMID: 32106721DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Serife Suna Oguz
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
- STUDY CHAIR
Nurdan Uras
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- NEONATOLOGY
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 22, 2016
Study Start
January 15, 2016
Primary Completion
June 30, 2017
Study Completion
October 15, 2019
Last Updated
October 4, 2019
Record last verified: 2019-10