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Clinical Trial Summary

The main objective of the study is to gather preliminary data on the effectiveness of High Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in newborns of 34-36 weeks with moderate respiratory distress syndrome (RDS).

The secondary objective is to evaluate the safety of HFNC in this indication.


Clinical Trial Description

Treatment with HFNC will start maximum 30 minutes after birth at an initial flow rate of 2L/Kg/min.

According to retraction signs, flow may be increased by gradual increments of 1L/min to reach a maximum flow rate of 5L/kg/minute.

Patients not improving after 2 hours of support with HFBNC will be hospitalized in the neonatal intensive care unit (NICU), and HFNC maintained as long as necessary, with regular attempts of weaning.

At any moment during the study, aggravation will lead to stop HFNC trial, and the infant management decided by the physician involved in the patient's care.

Aggravation is definined by one of the following conditions: Silverman-Anderson score > 6, and / or FiO2 > 0.5 and / or severe apneas and / or hemodynamic instability. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02958488
Study type Interventional
Source University Hospital, Montpellier
Contact Gilles Cambonie, Professor
Email g-cambonie@chu-montpellier.fr
Status Recruiting
Phase N/A
Start date March 16, 2016
Completion date March 2020

See also
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Completed NCT02793674 - HFNC Flow Titration and Effort of Breathing in the PICU N/A
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Not yet recruiting NCT04293991 - High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure N/A
Recruiting NCT06306651 - High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea N/A
Completed NCT03845244 - Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy N/A
Completed NCT04965844 - Closed-loop Oxygen Control for High Flow Nasal Therapy N/A
Not yet recruiting NCT05467332 - Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.
Completed NCT04325906 - Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS N/A
Completed NCT03529994 - Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)