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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Preterm Infant

Intervention / Treatment
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* Other: Vapotherm
* Other: NIPPV


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vapotherm arm<br>Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA | Other: Vapotherm<br>* A form of non invasive ventilation used in newborns<br>* Other names: Heated Humidified High Flow Nasal Cannula;|
| Experimental: NIPPV arm<br>Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator | Other: NIPPV<br>* A form of non invasive ventilation used in newborns<br>* Other names: Nasal Intermittent Positive Pressure Ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |