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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

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: NHF small cannula Device: NHF big cannula Device: CPAP Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Airway Pressure During Nasal High Flow and CPAP in Neonates
Study Start Date : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: NHF small cannula
NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow)
Device: NHF small cannula
NHF 8 l/min by Airvo 2 by small cannula
Other Name: Optiflow, HFNC

Experimental: NHF big cannula
NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple)
Device: NHF big cannula
NHF 8 l/min by Airvo 2 by large cannula
Other Name: Optiflow, HFNC

Experimental: Mask CPAP
CPAP 5cm H2O
Device: CPAP
Nsal CPAP 5cm H2o by face mask

No Intervention: no intervention
control



Primary Outcome Measures :
  1. Upper airway pressure generated by NHF compared to CPAP [ 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 term newborns

Exclusion Criteria:

  • Newborns with any medical problems after birth
  • Absent of parents consents

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): NCT02632799


Locations
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Armenia
Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health
Yerevan, Armenia, 0002
RCMCHP
Yerevan, Armenia, 0002
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 Research Center of Maternal and Child Health Protection, Armenia

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Responsible Party: Research Center of Maternal and Child Health Protection, Armenia
ClinicalTrials.gov Identifier: NCT02632799     History of Changes
Other Study ID Numbers: RCMCHP012
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
CPAP
airway pressure
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