Airway Pressure During Nasal High Flow and CPAP in Neonates

Not Applicable

Completed

• Conditions: Respiratory Insufficiency

• Registration Number: NCT02632799
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-17
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Healthy term newborns

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Upper airway pressure generated by NHF compared to CPAP	Up to 1 hour	Pressure in upper airways

Trial Locations

Locations (2)

Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health; 🇦🇲 Yerevan, Armenia

RCMCHP; 🇦🇲 Yerevan, Armenia