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Airway Pressure During Nasal High Flow and CPAP in Neonates

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ClinicalTrials.gov Identifier: NCT02632799
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Research Center of Maternal and Child Health Protection, Armenia

Tracking Information
First Submitted Date  ICMJE September 10, 2015
First Posted Date  ICMJE December 17, 2015
Last Update Posted Date December 17, 2015
Study Start Date  ICMJE January 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
Upper airway pressure generated by NHF compared to CPAP [ Time Frame: Up to 1 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Airway Pressure During Nasal High Flow and CPAP in Neonates
Official Title  ICMJE Airway Pressure During Nasal High Flow and CPAP in Neonates
Brief Summary Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. The aim of the study was to investigate airway pressure during NHF and CPAP in neonates.
Detailed Description Methods: A physiological study which measured pressure intra-nasally with micro (750 µm) pressure probes (Millar, USA) in 10 (5M / 5F) healthy newborns with mean gestation age 37.18 (SD 1.29) wk and mean birth weight of 2414 (SD 503.13) g. NHF was applied at 8 L/min (AIRVO 2) through smaller (OPT 314) and larger (OPT 316) Optiflow nasal cannula; CPAP 5 cmH20 was produced by a Bubble CPAP system and nasal mask interface at constant flow 8 L/min (Fisher & Paykel Healthcare, NZ). Values are expressed in cmH20 as means and standard deviations (SD).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Respiratory Insufficiency
Intervention  ICMJE
  • Device: NHF small cannula
    NHF 8 l/min by Airvo 2 by small cannula
    Other Name: Optiflow, HFNC
  • Device: NHF big cannula
    NHF 8 l/min by Airvo 2 by large cannula
    Other Name: Optiflow, HFNC
  • Device: CPAP
    Nsal CPAP 5cm H2o by face mask
Study Arms  ICMJE
  • Experimental: NHF small cannula
    NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow)
    Intervention: Device: NHF small cannula
  • Experimental: NHF big cannula
    NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple)
    Intervention: Device: NHF big cannula
  • Experimental: Mask CPAP
    CPAP 5cm H2O
    Intervention: Device: CPAP
  • No Intervention: no intervention
    control
Publications * Not Provided

*   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: December 14, 2015)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy term newborns

Exclusion Criteria:

  • Newborns with any medical problems after birth
  • Absent of parents consents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Armenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02632799
Other Study ID Numbers  ICMJE RCMCHP012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Research Center of Maternal and Child Health Protection, Armenia
Study Sponsor  ICMJE Research Center of Maternal and Child Health Protection, Armenia
Collaborators  ICMJE Fisher and Paykel Healthcare
Investigators  ICMJE
Principal Investigator: Pavel Mazmanyan, MD PhD Research Center of Maternal and Child Health Protection, Armenia
PRS Account Research Center of Maternal and Child Health Protection, Armenia
Verification Date September 2015

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