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

Not Applicable

• Conditions: Respiratory Distress Syndrome
• Interventions: Other: NCPAP; Other: NIPPV

• Registration Number: NCT04698473
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-15
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-07
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-22
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIPPV	NIPPV	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.
NCPAP	NCPAP	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.
NIPPV	NCPAP	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.
NCPAP	NIPPV	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.

Primary Outcome Measures

Name	Time	Method
Treatment failure within 72 hours after randomization 72 hours after randomization	within 72 hours after randomization	Need for invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Rate of bronchopulmonary dysplasia	36 weeks of postmenstrual age ]	defined according to the NICHD definition

Trial Locations

Locations (1)

Hilal Ozkan; 🇹🇷 Bursa, Select..., Turkey