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

NCT ID: NCT04698473

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-12-01

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

NCPAP

Intervention Type: OTHER

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

NIPPV

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

NCPAP

Intervention Type: OTHER

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

NIPPV

Intervention Type: OTHER

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

Interventions

NCPAP

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

Intervention Type: OTHER

NIPPV

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 29 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Hilal Ozkan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hilal ozkan

Role: STUDY_DIRECTOR

Study director

Locations

Hilal Ozkan

Bursa, Select..., Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

hilal ozkan, professor

Role: CONTACT

hiozkan@hotmail.com

+905327608083

Facility Contacts

hilal ozkan

Role: primary

hiozkan@hotmail.com

05327608083

References

Gopel W, Kribs A, Ziegler A, Laux R, Hoehn T, Wieg C, Siegel J, Avenarius S, von der Wense A, Vochem M, Groneck P, Weller U, Moller J, Hartel C, Haller S, Roth B, Herting E; German Neonatal Network. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet. 2011 Nov 5;378(9803):1627-34. doi: 10.1016/S0140-6736(11)60986-0. Epub 2011 Sep 29.

Reference Type: BACKGROUND

PMID: 21963186 (View on PubMed)

Lemyre B, Laughon M, Bose C, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD005384. doi: 10.1002/14651858.CD005384.pub2.

Reference Type: RESULT

PMID: 27976361 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-AKD-138

Identifier Type: -

Identifier Source: org_study_id