NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation
Primary Purpose
Intubation Complication, PreTerm Birth
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NIPPV
Sponsored by
About this trial
This is an interventional supportive care trial for Intubation Complication focused on measuring Neonatal, NIPPV, BIPAP, Extubation failure
Eligibility Criteria
Inclusion Criteria:
- Mechanically ventilated preterm infants with birthweight ≤1250 g
Exclusion Criteria:.
- Infants with major congenital malformations, neuromuscular disease and lack of parental consent
Sites / Locations
- Zekai Tahir Burak Maternity Teaching hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
NIPPV
BIPAP
Arm Description
NIPPV after ekstubation
BIPAP after ekstubation
Outcomes
Primary Outcome Measures
Rate of extubation failure
Secondary Outcome Measures
Full Information
NCT ID
NCT02842190
First Posted
July 20, 2016
Last Updated
October 1, 2019
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02842190
Brief Title
NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation
Official Title
Nasal Intermittent Positive Pressure Ventilation Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation in Infants ≤ 1250 g Birthweight
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2016 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
October 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In this study , mechanically ventilated preterm infants with birthweight ≤1250 g will screen for eligibility. Infants with major congenital malformations, neuromuscular disease and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and BIPAP group) following the decision to extubate by using sealed opaque envelopes. Extubation criteria are; loaded with caffeine according to standard clinical protocol, satisfactory blood gases (pH of more than 7.25), mean airway pressure of 7 cm water or less, fractional inspired oxygen concentration of 35 % or less and good respiratory effort.
Non-invasive respiratory support will deliver using the device of SLE 5000 (Specialised Laboratory Equipment, South Croydon, United Kingdom) in NIPPV group and infant flow- deriver device (Viasys Corp, Care Fusion, CA) in BIPAP group. The short binasal prongs will use as interface. The initial ventilator parameters for NIPPV were: PIP levels set 2 cm H2O above the pre-extubation PIP, PEEP: 5 cm H2O, rate the same as was being given before extubation and for BiPAP were: lower CPAP levels 4 to 6 cmH2O (maximum 7 cmH2O) and higher CPAP levels 8 to 9 cmH2O (maximum 10 cmH2O), Thigh 0.5-0.6 second, and a pressure exchange rate of 20-30/ minute, with the lowest adjusted FiO2 to maintain an oxygen saturation of 90% to 95%.
Extubation failure was defined as: development of respiratory acidosis (blood gases with pH < 7.2 and PaCO2> 60 mmHg), or hypoxemia (blood gases with PaO2 < 50 mmHg despite oxygen supplementation of 60 percent), or severe apnea requiring mask ventilation.
Surfactant requirement is goingto evaluate in all infants after NICU admission. Poractant alfa was administered if necessary.
The primary end-point, rate of extubation failure within 96 hours following first extubation, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Complication, PreTerm Birth
Keywords
Neonatal, NIPPV, BIPAP, Extubation failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NIPPV
Arm Type
Active Comparator
Arm Description
NIPPV after ekstubation
Arm Title
BIPAP
Arm Type
No Intervention
Arm Description
BIPAP after ekstubation
Intervention Type
Device
Intervention Name(s)
NIPPV
Intervention Description
after ekstubation
Primary Outcome Measure Information:
Title
Rate of extubation failure
Time Frame
within 96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mechanically ventilated preterm infants with birthweight ≤1250 g
Exclusion Criteria:.
Infants with major congenital malformations, neuromuscular disease and lack of parental consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NİLUFER OKUR, dr
Phone
+905065360059
Email
n.matur@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Buyuktiryaki
Phone
+903123065072
Email
mbuyuktiryaki@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serife Suna Oguz
Organizational Affiliation
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nurdan Uras
Organizational Affiliation
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Official's Role
Study Chair
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatmanur Sari, Assosiace professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
32106721
Citation
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.
Results Reference
derived
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NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation
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