Back to resultsComparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
Primary Purpose
Noninvasive Ventilation for Respiratory Distress Syndrome
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Nasal CPAP (SLE)
Nasal IMV (SLE)
Sponsored by
About this trial
This is an interventional treatment trial for Noninvasive Ventilation for Respiratory Distress Syndrome focused on measuring Nasal CPAP, Nasal IMV, Surfactant, Preterm infants
Eligibility Criteria
Inclusion Criteria:
- Gestational age 26-32 weeks
The criteria for failure were met by at least 1 of the following:
- pH: 7.10 and PaCO2: 70 mm Hg
- Recurrent apnea with >3 episodes (Prophylactic caffeine were used in all infants)
- Single episode of apnea that required bag-and-mask ventilation
- PaO2: 50 mmHg with a fraction of inspired oxygen of >0.5.
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 Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nasal Continuous Positive Airway Pressure (CPAP)
Nasal Intermittent Mandatory Ventilation (IMV)
Arm Description
After 2 hours evaluation: Infants needed invasive MV (mechanic ventilation) or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%. Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose
After 2 hours evaluation: Infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of > 88% to 92%. Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose
Outcomes
Primary Outcome Measures
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants
If infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective.
Secondary Outcome Measures
Complications of respiratory support
respiratory insufficiency, pneumothorax
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01741129
Brief Title
Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mehmet Yekta
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noninvasive Ventilation for Respiratory Distress Syndrome
Keywords
Nasal CPAP, Nasal IMV, Surfactant, Preterm infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal Continuous Positive Airway Pressure (CPAP)
Arm Type
Active Comparator
Arm Description
After 2 hours evaluation:
Infants needed invasive MV (mechanic ventilation) or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%.
Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose
Arm Title
Nasal Intermittent Mandatory Ventilation (IMV)
Arm Type
Active Comparator
Arm Description
After 2 hours evaluation:
Infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of > 88% to 92%.
Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose
Intervention Type
Device
Intervention Name(s)
Nasal CPAP (SLE)
Other Intervention Name(s)
SLE 2000, SLE 5000
Intervention Description
PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute
Intervention Type
Device
Intervention Name(s)
Nasal IMV (SLE)
Other Intervention Name(s)
SLE 2000, SLE 5000
Intervention Description
PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute
Primary Outcome Measure Information:
Title
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants
Description
If infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications of respiratory support
Description
respiratory insufficiency, pneumothorax
Time Frame
3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Gestational age 26-32 weeks
The criteria for failure were met by at least 1 of the following:
pH: 7.10 and PaCO2: 70 mm Hg
Recurrent apnea with >3 episodes (Prophylactic caffeine were used in all infants)
Single episode of apnea that required bag-and-mask ventilation
PaO2: 50 mmHg with a fraction of inspired oxygen of >0.5.
Exclusion Criteria:
Major congenital anomalies
Presence of cardiovascular instability
Intubation at admission to the NICU
Consent not provided or refused
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
26553376
Citation
Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, Canpolat FE, Oguz SS, Dilmen U. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F323-8. doi: 10.1136/archdischild-2015-308204. Epub 2015 Nov 9.
Results Reference
derived
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Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
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