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The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants
Patient population will include preterm infants born at 24 - 36+6 weeks of gestation who are candidates for non-invasive respiratory support post extubation or as primary respiratory support after birth. They will be will be randomized to 2 groups: Heated Humidified High Flow Nasal Cannula (HHHFNC) and Nasal Intermittent Positive Pressure Ventilation (NIPPV).
This will be a prospective unblinded randomized controlled study, designed as a non-inferiority trial.
Primary outcome: The primary outcome will be rate of treatment failure (need for intubation) within 7 days of starting the study treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vapotherm arm | Experimental | Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA |
|
| NIPPV arm | Experimental | Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vapotherm | Other | A form of non invasive ventilation used in newborns |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of intubation within 7 days of starting the study treatment | Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas | one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayala Gover, MD | Contact | 972-528-396948 | ayalagover@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ayala Gover, MD | Carmel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmel Medical Center | Recruiting | Haifa | Israel |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| NIPPV | Other | A form of non invasive ventilation used in newborns |
|
|
| D000091642 | Urogenital Diseases |