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

Primary Purpose

Respiratory Distress Syndrom, High Flow Nasal Cannula

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Distress Syndrom focused on measuring 34 to 36 Weeks Preterm Neonates, Respiratory Distress Syndrom, High Flow Nasal Cannula

Eligibility Criteria

34 Weeks - 36 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • University Hospital of MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preterm Neonates with Respiratory Distress Syndrome

Arm Description

34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome

Outcomes

Primary Outcome Measures

Total duration of noninvasive ventilation

Secondary Outcome Measures

Rate of hospitalization in NICU for RDS
Rate of RDS aggravation
Rate of intubation
Rate of good tolerance of LNHD technique
Incidence of side effects, including pain and discomfort, skin lesions, abdominal distension, air leak syndrome, necrotizing enterocolitis, hypothermia, hypoglycemia

Full Information

First Posted
August 5, 2016
Last Updated
June 12, 2018
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02958488
Brief Title
Efficacy and Tolerance of High Flow Nasal Cannula for Respiratory Distress Syndrom in Late Preterms (34-36 Weeks)
Acronym
PRIMAIR
Official Title
Prospective Efficacy and Tolerance Data Collection in 34 to 36 Weeks Preterm Neonates Treated by High Flow Nasal Cannula for Respiratory Distress Syndrom
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2016 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrom, High Flow Nasal Cannula
Keywords
34 to 36 Weeks Preterm Neonates, Respiratory Distress Syndrom, High Flow Nasal Cannula

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preterm Neonates with Respiratory Distress Syndrome
Arm Type
Experimental
Arm Description
34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula
Primary Outcome Measure Information:
Title
Total duration of noninvasive ventilation
Time Frame
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 Measure Information:
Title
Rate of hospitalization in NICU for RDS
Time Frame
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.
Title
Rate of RDS aggravation
Time Frame
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.
Title
Rate of intubation
Time Frame
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.
Title
Rate of good tolerance of LNHD technique
Time Frame
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.
Title
Incidence of side effects, including pain and discomfort, skin lesions, abdominal distension, air leak syndrome, necrotizing enterocolitis, hypothermia, hypoglycemia
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles Cambonie, Professor
Email
g-cambonie@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Cambonie, Professor
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Cambonie, Professor
Email
g-cambonie@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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