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Status unknownNCT03400670(NCPAP)Updated Jul 16, 2019

Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome

An interventional study of ventilator NCPAP in Ventilatory Failure, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Status unknown at 1 site in Turkey. Open to participants aged 1 Hour to 2 Hours. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jan 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
1 Hour to 2 Hours
Sex
All
01

Study summary

is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.

Read the detailed description

Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 \<0.30.

Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.

Non-invasive respiratory support failure is set as follows:

  • FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
  • Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
  • Persistent acidosis; presence of pH \< 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
  • Severe respiratory distress,
  • Pulmonary haemorrhage and cardiopulmonary arrest.
02

Conditions studied

  • Ventilatory Failure

Keywords

  • NCPAP
  • Respiratory Distress Syndrome
03

In context

Hypoventilation

96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.

This study's planned enrollment of 400 is above the median of 52 across 63 interventional studies indexed under Hypoventilation.

Browse Hypoventilation studies →

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital is the lead sponsor of 62 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 2 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included

Exclusion criteria

Exclusion Criteria:

  • Major congenital anomalies
  • Presence of cardiovascular instability
  • Intubation at admission to the NICU
  • Consent not provided or refused
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    Ventilator NCPAP

    neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O

    Device: ventilator NCPAP

  • Active comparator
    Infant Flow-driver NCPAP

    infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow

    Device: ventilator NCPAP

Interventions

  • Deviceventilator NCPAP

    infants will be randomized into two different NCPAP groups

    Also known as: infant flow driver NCPAP

06

What researchers measure

Primary outcomes

  1. noninvasive ventilation failure

    need for mechanical ventilation in the first 72 hours of life

    Time frame: 72 hours

07

Study locations

1 of 1 sites recruiting
  • Zekai Tahir Burak Maternity Teaching
    Ankara, 06230, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2017 (actual). Primary completion is estimated for Jan 2020, 36 months after the start.

Of 35 non-industry interventional studies with no phase under Hypoventilation, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 36 months is above that.

Counting every sponsor, half of 35 studies reached it within 15 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2017
First posted
Jan 17, 2018
StartActual
Jan 5, 2017
Primary completionEst.
Jan 5, 2020
CompletionEst.
Feb 5, 2020
Last update
Jul 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03400670
Lead sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Jan 5, 2017
Primary completion
Jan 5, 2020 (estimated)
Completion
Feb 5, 2020 (estimated)
Last update
Jul 16, 2019

Study contacts

Mehmet Büyüktiryaki, MD
Contact
mbuyuktiryaki@yahoo.com
+905054525576
Suna Oguz
Contact
serifesuna@gmail.com
+90 3123065270
Suna Oğuz
study director · Zekai Tahir Burak Women's Health Research and Education Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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