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

University Hospital Center (CHU)

Status: Completed

Conditions: High Flow Nasal Cannula; Respiratory Distress Syndrom

Treatments: Device: High Flow Nasal Cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT02958488

9606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 34 to 36 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Preterm Neonates with Respiratory Distress Syndrome

Experimental group

Description:

34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome

Treatment:

Device: High Flow Nasal Cannula