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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrom; High Flow Nasal Cannula
• Interventions: Device: High Flow Nasal Cannula

• Registration Number: NCT02958488
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Study Timeline

• Study Start: 2016-03-16
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Primary Completion: 2019-07
• Study Completion: 2020-08-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Newborn premature between 34 and 36 weeks of gestational age
• Moderate RDS after 30 minutes of life while treated with + 5cm H2O positive airway pressure
• Presence of a dedicated pediatric nurse and pediatrician
• Parental consent

Exclusion Criteria

• Need for early intubation
• Severe RDS, defined by one of the following: Silverman-Anderson score > 6, severe hypoxia (FiO2 > 0.5), hemodynamic disorders (HR> 180 / min, MABP <30mmHg, capillary refill time > 5s, pallor), and severe apneas (> 5s and / or with bradycardia <80 /min)
• 1 minute Apgar score < 3 and / or five minutes Apgar score < 7
• Birth weight < 1800g and / or IUGR <-2 SD
• Congenital heart, pulmonary, facial, or digestive malformation
• Subject not affiliated to social security system
• Legal representatives unable to understand the terms of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preterm Neonates with Respiratory Distress Syndrome	High Flow Nasal Cannula	34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome

Primary Outcome Measures

Name	Time	Method
Total duration of noninvasive ventilation	from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects, including pain and discomfort, skin lesions, abdominal distension, air leak syndrome, necrotizing enterocolitis, hypothermia, hypoglycemia	from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.
Rate of hospitalization in NICU for RDS	from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.
Rate of intubation	from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.
Rate of good tolerance of LNHD technique	from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.
Rate of RDS aggravation	from the first minute of life to the end of the hospitalization in the Department of Neonatal Medicine of Montpellier University Hospital Center, i .e. usually up to a minimal corrected gestationnal age of 36 weeks.

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, France