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Completed

NCT Number: NCT04698473

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

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Tract Diseases

Age range

24 week–29 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hilal Ozkan

Bursa, Select..., 16285, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nCPAP

Other

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

NIPPV

Other

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

Primary outcomes

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

    Time frame: within 72 hours after randomization

    Need for invasive mechanical ventilation

Secondary outcomes

  1. Rate of bronchopulmonary dysplasia

    Time frame: 36 weeks of postmenstrual age ]

    defined according to the NICHD definition

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2021
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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