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

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

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.

Study Overview

• Status: Completed
• Conditions: High Flow Nasal Cannula; Respiratory Distress Syndrom
• Intervention / Treatment: Device: High Flow Nasal Cannula

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preterm Neonates with Respiratory Distress Syndrome; 34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome	Device: High Flow Nasal Cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 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.
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.
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.

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Gilles Cambonie, Professor, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimated): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: High Flow Nasal Cannula; 34 to 36 Weeks Preterm Neonates; Respiratory Distress Syndrom
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 9606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED