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

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04698473
• Other study ID #: 18-AKD-138
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2021
• Source: Uludag University
• Contact: hilal ozkan, professor
• Phone: +905327608083
• Email: hiozkan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 29 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Turkey	Hilal Ozkan	Bursa	Select...

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Göpel 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, Möller J, Härtel 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. — View Citation

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:CD005384. doi: 10.1002/146 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure within 72 hours after randomization 72 hours after randomization	Need for invasive mechanical ventilation	within 72 hours after randomization
Secondary	Rate of bronchopulmonary dysplasia	defined according to the NICHD definition	36 weeks of postmenstrual age ]