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

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

Sponsors

Lead Sponsor: Uludag University

Source Uludag University
Brief Summary

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

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.

Overall Status Recruiting
Start Date December 1, 2020
Completion Date December 1, 2022
Primary Completion Date December 1, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Treatment failure within 72 hours after randomization 72 hours after randomization within 72 hours after randomization
Secondary Outcome
Measure Time Frame
Rate of bronchopulmonary dysplasia 36 weeks of postmenstrual age ]
Enrollment 170
Condition
Intervention

Intervention Type: Other

Intervention Name: NCPAP

Description: NCPAP infants will be randomized into two different non invasive ventilation groups

Intervention Type: Other

Intervention Name: NIPPV

Description: NIPPV NCPAP infants will be randomized into two different non invasive ventilation groups

Eligibility

Criteria:

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

Gender: All

Minimum Age: 24 Weeks

Maximum Age: 29 Weeks

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
hilal ozkan Study Director Study director
Overall Contact

Last Name: hilal ozkan, professor

Phone: +905327608083

Email: [email protected]

Location
Facility: Status: Contact: Hilal Ozkan hilal ozkan 05327608083 [email protected]
Location Countries

Turkey

Verification Date

January 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Uludag University

Investigator Full Name: Hilal Ozkan

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: NCPAP

Type: Active Comparator

Description: 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.

Label: NIPPV

Type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov