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Airway Pressure During Nasal High Flow and CPAP in Neonates

R

Research Center of Maternal and Child Health Protection, Armenia

Status

Completed

Conditions

Respiratory Insufficiency

Treatments

Device: CPAP
Device: NHF big cannula
Device: NHF small cannula

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02632799
RCMCHP012

Details and patient eligibility

About

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.

Full 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).

Enrollment

10 patients

Sex

All

Ages

1 to 3 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy term newborns

Exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 4 patient groups

NHF small cannula
Experimental group
Description:
NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow)
Treatment:
Device: NHF small cannula
NHF big cannula
Experimental group
Description:
NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple)
Treatment:
Device: NHF big cannula
Mask CPAP
Experimental group
Description:
CPAP 5cm H2O
Treatment:
Device: CPAP
no intervention
No Intervention group
Description:
control

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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