High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants
VAPORAM
A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants
1 other identifier
interventional
130
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2018
CompletedFirst Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedFebruary 9, 2021
February 1, 2021
3.9 years
February 19, 2019
February 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Vapotherm arm
EXPERIMENTALPreterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA
NIPPV arm
EXPERIMENTALPreterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carmel Medical Center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayala Gover, MD
Carmel Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 25, 2019
Study Start
January 21, 2018
Primary Completion
January 1, 2022
Study Completion
July 1, 2023
Last Updated
February 9, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share