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

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02958488
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 47.5
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrom; High Flow Nasal Cannula	Device: High Flow Nasal Cannula	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Mar 16, 2016
• Anticipated Primary Completion Date: Mar 1, 2020
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.]

2. 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.]

3. 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.]

4. 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.]

5. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 34 Weeks to 36 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Montpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT02958488
• Other Study ID Numbers: 9606
• First Posted: Nov 8, 2016
• Last Update Posted: Jun 13, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by University Hospital, Montpellier: 34 to 36 Weeks Preterm Neonates; Respiratory Distress Syndrom; High Flow Nasal Cannula
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Jun 13, 2018