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

NCT ID: NCT02958488

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-16
• Study Completion Date: 2020-08-25

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.

Conditions

Respiratory Distress Syndrom; High Flow Nasal Cannula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Preterm Neonates with Respiratory Distress Syndrome

34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome

Group Type: EXPERIMENTAL

High Flow Nasal Cannula

Intervention Type: DEVICE

Interventions

High Flow Nasal Cannula

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 34 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Cambonie, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

University Hospital of Montpellier

Montpellier, , France

Countries

France

Other Identifiers

9606

Identifier Type: -

Identifier Source: org_study_id