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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Distress Syndrom, High Flow Nasal Cannula

Intervention / Treatment
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* Device: High Flow Nasal Cannula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 34 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preterm Neonates with Respiratory Distress Syndrome<br>34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome | Device: High Flow Nasal Cannula<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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34 to 36 Weeks Preterm Neonates, Respiratory Distress Syndrom, High Flow Nasal Cannula