NCT02958488

Efficacy and Tolerance of High Flow Nasal Cannula for Respiratory Distress Syndrom in Late Preterms (34-36 Weeks)

Prospective Efficacy and Tolerance Data Collection in 34 to 36 Weeks Preterm Neonates Treated by High Flow Nasal Cannula for Respiratory Distress Syndrom

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 34 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Respiratory Distress Syndrom
• High Flow Nasal Cannula

Interventions

Type	Name	Description
DEVICE	High Flow Nasal Cannula

Timeline

• Start date: 2016-03-16
• Primary completion: 2019-07-01
• Completion: 2020-08-25
• First posted: 2016-11-08
• Last updated: 2024-05-29

Locations

1 site across 1 country: France