High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants
NCT ID: NCT03853161
Last Updated: 2021-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
130 participants
INTERVENTIONAL
2018-01-21
2023-07-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vapotherm arm
Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA
Vapotherm
A form of non invasive ventilation used in newborns
NIPPV arm
Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator
NIPPV
A form of non invasive ventilation used in newborns
Interventions
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Vapotherm
A form of non invasive ventilation used in newborns
NIPPV
A form of non invasive ventilation used in newborns
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Carmel Medical Center
OTHER
Responsible Party
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Ayala Gover
principal investigator
Principal Investigators
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Ayala Gover, MD
Role: PRINCIPAL_INVESTIGATOR
Carmel Medical Center
Locations
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Carmel Medical Center
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMC-17-0131-CTIL
Identifier Type: -
Identifier Source: org_study_id
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