Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741129
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital

Tracking Information
First Submitted Date  ICMJE November 26, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date March 10, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2013)
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants [ Time Frame: 3 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
Efficacy of nasal synchronized intermittent mandatory ventilation (SIMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants [ Time Frame: 3 months ]
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 SIMV or CPAP is ineffective.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
Complications of respiratory support [ Time Frame: 3 months ]
respiratory insufficiency, pneumothorax
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Noninvasive Ventilation for Respiratory Distress Syndrome
Intervention  ICMJE
  • Device: Nasal CPAP (SLE)
    PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute
    Other Name: SLE 2000, SLE 5000
  • Device: Nasal IMV (SLE)
    PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute
    Other Name: SLE 2000, SLE 5000
Study Arms  ICMJE
  • Active Comparator: Nasal Continuous Positive Airway Pressure (CPAP)

    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
    Intervention: Device: Nasal CPAP (SLE)
  • Active Comparator: Nasal Intermittent Mandatory Ventilation (IMV)

    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: Device: Nasal IMV (SLE)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741129
Other Study ID Numbers  ICMJE ZTB2611
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
Study Sponsor  ICMJE Mehmet Yekta
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zekai Tahir Burak Women's Health Research and Education Hospital
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP