Comparison of Efficacy of Less Invasive Surfactant Treatment Under Nasal CPAP and Nasal IPPV

Study Overview
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Brief Summary
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Non invasive ventilation is important in the care of preterm infants with respiratory failure, and surfactant treatment can be use with non invasive ventilation. However, there is no consensus on the best non-invasive ventilation mode for surfactant treatment in preterm infants. Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (CPAP) in preterm infants ≤ 29 week gestational age.

Detailed Description
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This CURLISPAP study was a multicenter, randomized controlled study at six level III neonatal intensive care units (NICUs) in Turkey. The protocol was approved by the ethics committee of each participating centre and Turkish Ministry of Health, Turkish Medicines and Medical Devices Agency. Non invasive ventilated preterm infants with respiratory distress syndrome and gestational age from 241/7 weeks to 296/7 weeks were enrolled within 6 h of birth. Infants with major congenital malformations, need of mechanical ventiation, need of entubation in delivery room and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and CPAP group). The short binasal prongs will use as interface. For all the groups, if the fraction of inspired oxygen (FiO2) requirement is persistently higher than 0.30 target SpO2 90-94%. For all groups Surfactant by LISA technique and with special catheter (LISAcath, Chiesi Pharmaceutics) of surfactant (Curosurf, Chiesi Pharmaceutics) 200 mg/kg. The primary end-point, need of mechanical ventilation within 72 hours following surfactant treatment, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.

Official Title
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Comparison of Efficacy of Less Invasive Surfactant Treatment Under Nasal CPAP and Nasal IPPV in Premature Babies: CURLISPAP Study

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Other: NCPAP
* Other: NIPPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age 24 -29 week Clinical and radiological diagnosis of RDS Born in a hospital with a study center Spontaneous breathing Within the first 6 hours Non-invasive ventilation and FiO2 requirement >0.30 Parental concent Exclusion Criteria: Major congenital malformations Need of mechanical ventiation Need of entubation in delivery room Air weak syndrome No parental concent

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 29 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: NCPAP<br>Ventilator-derived NCPAP will be administered using binasal prongs. Standard Devices or infant flow-driver device. Initial NCPAP settings are: PEEP:6 cmH2O and FiO2: adjusted to keep preductal sPO2 between %90-94. Failure is defined as FiO2 requirement of >%50, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>60 cmH2O. | Other: NCPAP<br>* NCPAP infants will be randomized into two different non invasive ventilation groups<br>Other: NIPPV<br>* NIPPV NCPAP infants will be randomized into two different non invasive ventilation groups<br>|
| Active Comparator: NIPPV<br>Ventilator-derived NIPPV will be administered using binasal prongs. Standard Devices or infant flow-driver device. Initial NIPPV settings are: PEEP:6 cmH2O, PIP: 15 cmH2O, Rate: 30-40/ bpm and FiO2: adjusted to keep preductal sPO2 between %90-94. Failure is defined as FiO2 requirement of >%50, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>60 cmH2O. | Other: NCPAP<br>* NCPAP infants will be randomized into two different non invasive ventilation groups<br>Other: NIPPV<br>* NIPPV NCPAP infants will be randomized into two different non invasive ventilation groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure within 72 hours after randomization 72 hours after randomization | Need for invasive mechanical ventilation | within 72 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bronchopulmonary dysplasia | defined according to the NICHD definition | 36 weeks of postmenstrual age ] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NCPAP, NIPPV, LISA