Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome ((NCPAP))
Primary Purpose
Ventilatory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ventilator NCPAP
Sponsored by
About this trial
This is an interventional treatment trial for Ventilatory Failure focused on measuring NCPAP, Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included
Exclusion Criteria:
- Major congenital anomalies
- Presence of cardiovascular instability
- Intubation at admission to the NICU
- Consent not provided or refused
Sites / Locations
- Zekai Tahir Burak Maternity TeachingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ventilator NCPAP
Infant Flow-driver NCPAP
Arm Description
neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O
infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow
Outcomes
Primary Outcome Measures
noninvasive ventilation failure
need for mechanical ventilation in the first 72 hours of life
Secondary Outcome Measures
Full Information
NCT ID
NCT03400670
First Posted
December 11, 2017
Last Updated
July 15, 2019
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03400670
Brief Title
Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome
Acronym
(NCPAP)
Official Title
Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
January 5, 2020 (Anticipated)
Study Completion Date
February 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Detailed Description
Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 <0.30.
Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.
Non-invasive respiratory support failure is set as follows:
FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
Severe respiratory distress,
Pulmonary haemorrhage and cardiopulmonary arrest.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Failure
Keywords
NCPAP, Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ventilator NCPAP
Arm Type
Active Comparator
Arm Description
neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O
Arm Title
Infant Flow-driver NCPAP
Arm Type
Active Comparator
Arm Description
infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow
Intervention Type
Device
Intervention Name(s)
ventilator NCPAP
Other Intervention Name(s)
infant flow driver NCPAP
Intervention Description
infants will be randomized into two different NCPAP groups
Primary Outcome Measure Information:
Title
noninvasive ventilation failure
Description
need for mechanical ventilation in the first 72 hours of life
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included
Exclusion Criteria:
Major congenital anomalies
Presence of cardiovascular instability
Intubation at admission to the NICU
Consent not provided or refused
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Büyüktiryaki, MD
Phone
+905054525576
Email
mbuyuktiryaki@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suna Oguz
Phone
+90 3123065270
Email
serifesuna@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suna Oğuz
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Buyuktiryaki
Phone
+905054525576
Email
mbuyuktiryaki@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome
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