ClinicalTrials.gg
Status unknownNCT02842190Updated Oct 4, 2019

NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation

An interventional study of NIPPV in Intubation Complication and PreTerm Birth, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Status unknown at 1 site in Turkey. Open to participants aged 1 Day to 14 Days. Per ClinicalTrials.gov, last updated 2019-10-04.

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

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
1 Day to 14 Days
Sex
All
01

Study summary

Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants.

Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following extubation in preterm infants ≤ 1250 g birthweight.

Read the detailed description

In this study , mechanically ventilated preterm infants with birthweight ≤1250 g will screen for eligibility. Infants with major congenital malformations, neuromuscular disease and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and BIPAP group) following the decision to extubate by using sealed opaque envelopes. Extubation criteria are; loaded with caffeine according to standard clinical protocol, satisfactory blood gases (pH of more than 7.25), mean airway pressure of 7 cm water or less, fractional inspired oxygen concentration of 35 % or less and good respiratory effort.

Non-invasive respiratory support will deliver using the device of SLE 5000 (Specialised Laboratory Equipment, South Croydon, United Kingdom) in NIPPV group and infant flow- deriver device (Viasys Corp, Care Fusion, CA) in BIPAP group. The short binasal prongs will use as interface. The initial ventilator parameters for NIPPV were: PIP levels set 2 cm H2O above the pre-extubation PIP, PEEP: 5 cm H2O, rate the same as was being given before extubation and for BiPAP were: lower CPAP levels 4 to 6 cmH2O (maximum 7 cmH2O) and higher CPAP levels 8 to 9 cmH2O (maximum 10 cmH2O), Thigh 0.5-0.6 second, and a pressure exchange rate of 20-30/ minute, with the lowest adjusted FiO2 to maintain an oxygen saturation of 90% to 95%.

Extubation failure was defined as: development of respiratory acidosis (blood gases with pH \< 7.2 and PaCO2> 60 mmHg), or hypoxemia (blood gases with PaO2 \< 50 mmHg despite oxygen supplementation of 60 percent), or severe apnea requiring mask ventilation.

Surfactant requirement is goingto evaluate in all infants after NICU admission. Poractant alfa was administered if necessary.

The primary end-point, rate of extubation failure within 96 hours following first extubation, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.

02

Conditions studied

  • Intubation Complication
  • PreTerm Birth

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Keywords

  • Neonatal
  • NIPPV
  • BIPAP
  • Extubation failure
03

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's planned enrollment of 140 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Browse Premature Birth 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 Day to 14 Days
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Mechanically ventilated preterm infants with birthweight ≤1250 g

Exclusion Criteria:.

  • Infants with major congenital malformations, neuromuscular disease and lack of parental consent
05

Study design

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

Study arms

  • Active comparator
    NIPPV

    NIPPV after ekstubation

    Device: NIPPV

  • No intervention
    BIPAP

    BIPAP after ekstubation

Interventions

  • DeviceNIPPV

    after ekstubation

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What researchers measure

Primary outcomes

  1. Rate of extubation failure

    Time frame: within 96 hours

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Study locations

1 of 1 sites recruiting
  • Zekai Tahir Burak Maternity Teaching hospital
    Ankara, Turkey
    Recruiting
    • Fatmanur Sari, Assosiace professor · Contact
08

References and documents

Publications

  • Okur N, Buyuktiryaki M, Sari FN, Dizdar EA, Oguz SS. Ventilator-delivered nasal intermittent positive pressure ventilation versus nasal biphasic positive airway pressure following extubation in infants </=1250 g birth weight: a randomized trial. J Matern Fetal Neonatal Med. 2022 Feb;35(4):752-758. doi: 10.1080/14767058.2020.1731462. Epub 2020 Feb 27. PubMed 32106721 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2016, a primary completion of Jun 2017 and a completion of Oct 2019. It does not say whether these dates are actual or estimated.

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

Registered
Jul 20, 2016
First posted
Jul 22, 2016
Start
Jan 15, 2016
Primary completionActual
Jun 30, 2017
CompletionEst.
Oct 15, 2019
Last update
Oct 4, 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 Oct 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02842190
Lead sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Responsible party
nilüfer okur (NEONATOLOGY, Zekai Tahir Burak Women's Health Research and Education Hospital) — Principal investigator
First posted
Jul 22, 2016
Start date
Jan 15, 2016
Primary completion
Jun 30, 2017
Completion
Oct 15, 2019 (estimated)
Last update
Oct 4, 2019

Study contacts

NİLUFER OKUR, dr
Contact
n.matur@hotmail.com
+905065360059
Mehmet Buyuktiryaki
Contact
mbuyuktiryaki@yahoo.com
+903123065072
Serife Suna Oguz
study director · Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Nurdan Uras
study chair · Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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