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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

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Nasal High Flow Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Nasal High Flow
NHF will be applied at 8 L/min (AIRVO 2) through (OPT 316) Optiflow nasal cannula interface without supplemental oxygen
Device: Nasal High Flow
Nasal High Flow Therapy

No Intervention: Control
Control is no NHF intervention



Primary Outcome Measures :
  1. Change of minute ventilation [ Time Frame: Up to 1 hour ]

Secondary Outcome Measures :
  1. Blood carbon dioxide [ Time Frame: Up to 1 hour ]
  2. Oxygen levels [ Time Frame: Up to 1 hour ]
  3. Oxygen saturation [ Time Frame: Up to 1 hour ]
  4. Heart rate [ Time Frame: Up to 1 hour ]


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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632825


Contacts
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Contact: Pavel Mazmanyan, MD, PhD +37491416589 pavelart@gmail.com
Contact: Stanislav Stanislav Tatkov, MD, PhD +64212580270 Stanislav.Tatkov@fphcare.co.nz

Locations
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Armenia
Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health Recruiting
Yerevan, Armenia, 0002
Contact: Pavel Mazmanyan, Dr    +37491 416589    pavelart@gmail.com   
Sponsors and Collaborators
Research Center of Maternal and Child Health Protection, Armenia
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Pavel Mazmanyan, MD, PhD Head of Neonatal Unit of Research Centre of Maternal and Child Health

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Responsible Party: Research Center of Maternal and Child Health Protection, Armenia
ClinicalTrials.gov Identifier: NCT02632825     History of Changes
Other Study ID Numbers: RCMCHP014
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: September 2015

Keywords provided by Research Center of Maternal and Child Health Protection, Armenia:
Nasal High Flow
gas exchange
newborn

Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases