Preterm Infant
Conditions
Brief summary
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
Detailed description
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
Interventions
OTHERVapotherm
A form of non invasive ventilation used in newborns
OTHERNIPPV
A form of non invasive ventilation used in newborns
Sponsors
Carmel Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures. * Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation. * Signed parental informed consent by one of the parents
Exclusion criteria
* Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities * Presence of a pneumothorax prior to enrollment * Hemodynamic instability due to sepsis or hemorrhage * Inability to obtain parental consent * Shortage of suitable equipment * Infants who were intubated solely for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of intubation within 7 days of starting the study treatment | one week | Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas |
Countries
Israel
Contacts
Primary ContactAyala Gover, MD
Outcome results
None listed