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

Not Applicable

• Conditions: Preterm Infant
• Interventions: Other: NIPPV; Other: Vapotherm

• Registration Number: NCT03853161
• Lead Sponsor: Carmel Medical Center

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

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

Study Timeline

• Study Start: 2018-01-21
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-07
• Last Update Posted: 2021-02-09
• Primary Completion: 2022-01-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIPPV arm	NIPPV	Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator
Vapotherm arm	Vapotherm	Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA

Primary Outcome Measures

Name	Time	Method
Rate of intubation within 7 days of starting the study treatment	one week	Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel