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Completed

NCT Number: NCT02632799

Airway Pressure During Nasal High Flow and CPAP in Neonates

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.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy term newborns

Exclusion criteria

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

Treatment and study plan

NHF small cannula

Device

NHF 8 l/min by Airvo 2 by small cannula

Other names: Optiflow, HFNC

NHF big cannula

Device

NHF 8 l/min by Airvo 2 by large cannula

Other names: Optiflow, HFNC

CPAP

Device

Nsal CPAP 5cm H2o by face mask

Primary outcomes

  1. Upper airway pressure generated by NHF compared to CPAP

    Time frame: Up to 1 hour

    Pressure in upper airways

Sponsors and collaborators

Lead sponsor

Research Center of Maternal and Child Health Protection, Armenia

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2015
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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