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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm Neonates with Respiratory Distress Syndrome | Experimental | 34 to 36 Weeks Preterm Neonates with Respiratory Distress Syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Nasal Cannula | Device |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Cambonie, Professor | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Montpellier | Montpellier | 34295 | France |
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| 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. |