NCT04698473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

December 15, 2020

Last Update Submit

February 4, 2026

Conditions

Respiratory Distress Syndrome

Keywords

NCPAPNIPPVLISA

Outcome Measures

Primary Outcomes (1)

  • Treatment failure within 72 hours after randomization 72 hours after randomization

    Need for invasive mechanical ventilation

    within 72 hours after randomization

Secondary Outcomes (1)

  • Rate of bronchopulmonary dysplasia

    36 weeks of postmenstrual age ]

Study Arms (2)

NCPAP

ACTIVE COMPARATOR

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: NCPAPOther: NIPPV

NIPPV

ACTIVE COMPARATOR

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: NCPAPOther: NIPPV

Interventions

NCPAPOTHER

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

NCPAPNIPPV
NIPPVOTHER

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

NCPAPNIPPV

Eligibility Criteria

Age24 Weeks - 29 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Major congenital malformations
  • Need of mechanical ventiation
  • Need of entubation in delivery room
  • Air weak syndrome
  • No parental concent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilal Ozkan

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

Location

Related Publications (2)

  • 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.

    PMID: 21963186BACKGROUND

  • 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.

    PMID: 27976361RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • hilal ozkan

    Study director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2020

First Posted

January 7, 2021

Study Start

October 1, 2020

Primary Completion

May 1, 2022

Study Completion

December 1, 2022

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)