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Status unknownNCT01499238Updated Dec 26, 2011

Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn

A Phase 4 interventional study of Nasal SIMV and nasal CPAP in Transient Tachypnea of Newborn, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Status unknown at 2 sites in Turkey. Open to participants aged 2 Hours to 3 Days. Per ClinicalTrials.gov, last updated 2011-12-26.

Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
2 Hours to 3 Days
Sex
All
01

Study summary

The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.

Read the detailed description

We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are >35 gestational week.

02

Conditions studied

  • Transient Tachypnea of Newborn

Keywords

  • Efficacy
  • safety
  • nasal SIMV
  • nasal CPAP
  • infants who are >35 gestational week with wet lung
03

In context

Tachypnea

39 studies on the registry are indexed under Tachypnea; 4 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 30 interventional studies indexed under Tachypnea.

Browse Tachypnea 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
2 Hours to 3 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • >35 gestational week
  • wetlung

Exclusion criteria

Exclusion Criteria:

  • major congenital anomalies
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    nasal SIMV

    rate: 30-50/min, PIP: 16, PEEP: 4-6, fİO2: 40%

    Device: Nasal SIMV

  • Active comparator
    nasal CPAP

    PEEP: 4-6 mmHg, Fio2: 40%

    Device: nasal CPAP

Interventions

  • DeviceNasal SIMV

    rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%

    Also known as: nasal SIMV, SLE 5000

  • Devicenasal CPAP

    PEEP: 4-6 mmHg, FİO2: 40%

    Also known as: NASAL CPAP, SLE 5000

06

What researchers measure

Primary outcomes

  1. efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age

    Time frame: 3 months

Secondary outcomes

  1. Complications of respiratory support, respiratory insufficiency

    pneumothorax

    Time frame: 3 months

07

Study locations

2 of 2 sites recruiting
  • Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
    Ankara, Turkey
    • Gamze Demirel, MD · Contact · kgamze@hotmail.com
    • Gamze Demirel, MD · Principal investigator
    Recruiting
  • Zekai Tahir Burak Maternity Teaching Hospital
    Ankara, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01499238
Lead sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Responsible party
Gamze Demirel (Zekai Tahir Burak Maternity Teaching Hospital, Zekai Tahir Burak Women's Health Research and Education Hospital) — Principal investigator
First posted
Dec 26, 2011
Start date
Dec 2011
Primary completion
Feb 2012 (estimated)
Completion
Mar 2012 (estimated)
Last update
Dec 26, 2011

Study contacts

Gamze Demirel, MD
Contact
kgamze@hotmail.com
Gamze Demirel, MD
principal investigator · Zekai Tahir Burak Women's Health Research and Education Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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