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

Sponsor
Uludag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04698473
Collaborator
(none)
170
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: NCPAP
  • Other: NIPPV
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Efficacy of Less Invasive Surfactant Treatment Under Nasal CPAP and Nasal IPPV in Premature Babies: CURLISPAP Study
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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

Other: NIPPV
NIPPV NCPAP infants will be randomized into two different non invasive ventilation groups
Active Comparator: 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.

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

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

Outcome Measures

Primary Outcome Measures

  1. Treatment failure within 72 hours after randomization 72 hours after randomization [within 72 hours after randomization]

    Need for invasive mechanical ventilation

Secondary Outcome Measures

  1. Rate of bronchopulmonary dysplasia [36 weeks of postmenstrual age ]]

    defined according to the NICHD definition

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Weeks to 29 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hilal Ozkan Bursa Select... Turkey 16285

Sponsors and Collaborators

  • Uludag University

Investigators

  • Study Director: hilal ozkan, Study director

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Hilal Ozkan, Professor, Uludag University
ClinicalTrials.gov Identifier:
NCT04698473
Other Study ID Numbers:
  • 18-AKD-138
First Posted:
Jan 7, 2021
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hilal Ozkan, Professor, Uludag University
NCPAP
NIPPV
LISA
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Jan 22, 2021