High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants

Preterm Infant Clinical Trial

— VAPORAM  

Official title:

A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03853161
• Other study ID #: CMC-17-0131-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2018
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2021
• Source: Carmel Medical Center
• Contact: Ayala Gover, MD
• Phone: 972-528-396948
• Email: ayalagover[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: July 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Other:
• Vapotherm
A form of non invasive ventilation used in newborns
• NIPPV
A form of non invasive ventilation used in newborns

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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