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NCT02632799 Clinical Trial

Airway Pressure During Nasal High Flow and CPAP in Neonates

Respiratory Insufficiency Clinical Trial

Official title:
Airway Pressure During Nasal High Flow and CPAP in Neonates

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02632799
Other study ID # RCMCHP012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date August 2015

Study information
Verified date October 2019
Source Research Center of Maternal and Child Health Protection, Armenia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 3 Days
Eligibility Inclusion Criteria:

- Healthy term newborns

Exclusion Criteria:

- Newborns with any medical problems after birth

- Absent of parents consents

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NHF small cannula
NHF 8 l/min by Airvo 2 by small cannula
• NHF big cannula
NHF 8 l/min by Airvo 2 by large cannula
• CPAP
Nsal CPAP 5cm H2o by face mask

Locations
Country Name City State
Armenia Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health Yerevan
Armenia RCMCHP Yerevan

Sponsors (2)
Lead Sponsor Collaborator
Research Center of Maternal and Child Health Protection, Armenia Fisher and Paykel Healthcare

Country where clinical trial is conducted

Armenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Upper airway pressure generated by NHF compared to CPAP Pressure in upper airways Up to 1 hour
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