High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome

Study Overview
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Brief Summary
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To compare the primary outcome, failure of extubation defined by the need for re-intubation and mechanical ventilation within 5 days of initial extubation and secondary outcomes, morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.

Detailed Description
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Inclusion criteria were: 1) Preterm neonates with gestational age of 24 to 28 completed weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3) Success to wean with 24 hours to extubate. 4) Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery. Exclusion criteria were: 1) Evidence of severe birth asphyxia. 2) Known genetic or chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity. 5) Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol. Randomization A computer-generated block-randomization sequence with random block sizes was used. Infants who were part of multiple births underwent individual randomization. Clinicians opened consecutively numbered, sealed, brown envelopes immediately before extubation to determine the study-group assignment.

Official Title
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Randomized Control Trial: Heated Humidity High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome in Extreme Low Birth Infants in Immediate Post Extubation Period

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Device: HHHFNC
* Device: NCPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm neonates with gestational age of 24 to 28 completed weeks. In the case of twins, both neonates were included in the same treatment arm. Success to wean with 24 hours to extubate. Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery. Exclusion Criteria: Evidence of severe birth asphyxia. Known genetic or chromosomal disorders. Infants delivered to mothers with ruptured membranes of more than three weeks duration. Potentially life-threatening conditions unrelated to prematurity. Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HHHFNC<br>Randomized to HHHFNC | Device: HHHFNC<br>* Tri-Anim Vaptherm the Precision Flow, which is a self contained unit that provides flow rates up to or 8 LPM (Infants) of blended oxygen that is heated and humidified<br>* Other names: VAPOTHERM;|
| Active Comparator: NCPAP<br>Randomized to NCPAP | Device: NCPAP<br>* Bubble CPAP System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the need for re-intubation | The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation. | 5 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of respiratory support using HHHFNC /NCPAP. |  | through study completion, an average of 1 year. | 
| Incidence of nasal breakdown |  | through study completion, an average of 24 weeks | 
| sepsis |  | through study completion, an average of 1 year. | 
| intraventricular hemorrhage (IVH), |  | through study completion, an average of 24 weeks | 
| retinopathy of prematurity (ROP) | number of participants with sepsis will be compared between the two arms. Sepsis was defined as a positive culture result from blood with concomitant clinical symptoms. Positive cultures were defined as having positive growth from the cerebrospinal fluid, tracheal, blood, or urine specimens. | through study completion, an average of 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cpap, HHHFNC, RDS, ELBW