NCT03853161

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Preterm Infant

Interventions

Type	Name	Description
OTHER	Vapotherm	A form of non invasive ventilation used in newborns
OTHER	NIPPV	A form of non invasive ventilation used in newborns

Timeline

• Start date: 2018-01-21
• Primary completion: 2022-01-01
• Completion: 2023-07-01
• First posted: 2019-02-25
• Last updated: 2021-02-09

Locations

1 site across 1 country: Israel