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Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange in Healthy Newborns

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ClinicalTrials.gov Identifier: NCT02632825
Recruitment Status : Unknown
Verified September 2015 by Research Center of Maternal and Child Health Protection, Armenia.
Recruitment status was:  Recruiting
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 May 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
Change of minute ventilation [ Time Frame: Up to 1 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • Blood carbon dioxide [ Time Frame: Up to 1 hour ]
  • Oxygen levels [ Time Frame: Up to 1 hour ]
  • Oxygen saturation [ Time Frame: Up to 1 hour ]
  • Heart rate [ Time Frame: Up to 1 hour ]
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 Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange in Healthy Newborns
Official Title  ICMJE Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange During Wakefulness and Sleep in Healthy Newborn Babies in a Randomized Crossover Study Design
Brief Summary Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. It has been shown in adults that NHF produce different effects on ventilation during wakefulness and sleep. There is no physiological data on effects of NHF in neonates. The physiological effects may be impacted by sleep/awake status.
Detailed Description

The aim of the study to investigate the effects of NHF therapy on ventilation and gas exchange during wakefulness and sleep in healthy term newborns.

Interventions:

NHF will be applied at 8 L/min (AIRVO 2) via (OPT 316) Optiflow nasal cannula interface without supplemental oxygen. Participants will act as their own control (no intervention) in a randomized crossover study design.

Physiological measurements:

  1. Ventilation will be assessed using Respiratory Inductance Plethysmography (RIP) (Respitrace QDC, Viasys, USA).
  2. Blood carbon dioxide (CO2) and oxygen levels will be measured by a non-invasive transcutaneous monitor (Tosca, Radiometer, Demnark).
  3. All experiment will be recorded using Analogue-to-Digital converter (Powerlab, ADInstruments, New Zealand) and LabChart software with video recording of the patient.
  4. Sleep/awake statuss will be determined by videorecording of the patient and Electroencephalogram (EEG) (Alice Polysomnography System Philips, USA)
  5. The total study time will be <3 hours in total for each participant. Routine measurement of heart rate, respiratory rate and oxygen saturation will be performed as per standard neonatal clinical practice.
  6. Intervention can be terminated if at any time SpO2 drops below 80%, TcCO2 increases above 60 mm Hg, Respiratory Rate increases above 80 breaths per min for more than one minute).

The researcher is an experienced neonatal consultant will be conducting the research and observing the baby throughout the study.

Protocol:

Both control and NHF intervention periods will last a maximum of 40 min each. The maximum duration of the study including set-up, calibration, intervention, washout ans control will be <3 hours. At the beginning of the study when all probes are attached a self-calibration period of RIP will be followed by a calibration of breathing volume with a pneumotachometer attached to a nasal mask. After all calibrations are completed a baseline measurement will be followed by either NHF 8 L/min or a control period without NHF. At the end of this period the interventions will be changes either to control or NHF, which will follow by a washout period (no NHF) and an additional calibration of RIP with a pneumotachometer.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Insufficiency
Intervention  ICMJE Device: Nasal High Flow
Nasal High Flow Therapy
Study Arms  ICMJE
  • Experimental: Nasal High Flow
    NHF will be applied at 8 L/min (AIRVO 2) through (OPT 316) Optiflow nasal cannula interface without supplemental oxygen
    Intervention: Device: Nasal High Flow
  • No Intervention: Control
    Control is no NHF intervention
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 16, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy full or near full-term newborns of 1-2 days of age.
  • A parent has given written informed consent to their baby's participation.

Exclusion Criteria:

  • Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician or required supplemental oxygen.
  • Known upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly.
  • A parent has not given written informed consent.
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 NCT02632825
Other Study ID Numbers  ICMJE RCMCHP014
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 Head of Neonatal Unit of Research Centre of Maternal and Child Health
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