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

Carmel Medical Center130 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Preterm Infant

Interventions

VapothermOTHER

A form of non invasive ventilation used in newborns

NIPPVOTHER

A form of non invasive ventilation used in newborns

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Carmel Medical Center

Haifa, Israel

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: one week

Central Contacts

Ayala Gover, MD

CONTACT

972-528-396948 ayalagover@gmail.com

Data from ClinicalTrials.gov

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