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

Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01499238
Collaborator
(none)
40
Enrollment
2
Locations
2
Arms
3
Duration (Months)
20
Patients Per Site
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Nasal SIMV
  • Device: nasal CPAP
 Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn
Study Start Date :
Dec 1, 2011
Anticipated Primary Completion Date :
Feb 1, 2012
Anticipated Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: nasal SIMV

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

Device: Nasal SIMV
rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%
Other Names:
  • nasal SIMV, SLE 5000

    		•
    Active Comparator: nasal CPAP

    PEEP: 4-6 mmHg, Fio2: 40%

    Device: nasal CPAP
    PEEP: 4-6 mmHg, FİO2: 40%
    Other Names:
  • NASAL CPAP, SLE 5000

    		•

    Outcome Measures

    Primary Outcome Measures

    1. efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age [3 months]

    Secondary Outcome Measures

    1. Complications of respiratory support, respiratory insufficiency [3 months]

      pneumothorax

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Hours to 3 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 35 gestational week

    • wetlung

    Exclusion Criteria:
    • major congenital anomalies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology Ankara Turkey
    2 Zekai Tahir Burak Maternity Teaching Hospital Ankara Turkey

    Sponsors and Collaborators

    • Zekai Tahir Burak Women's Health Research and Education Hospital

    Investigators

    • Principal Investigator: Gamze Demirel, MD, Zekai Tahir Burak Women's Health Research and Education Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gamze Demirel, Zekai Tahir Burak Maternity Teaching Hospital, Zekai Tahir Burak Women's Health Research and Education Hospital
    ClinicalTrials.gov Identifier:
    NCT01499238
    Other Study ID Numbers:
    • 4
    First Posted:
    Dec 26, 2011
    Last Update Posted:
    Dec 26, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by Gamze Demirel, Zekai Tahir Burak Maternity Teaching Hospital, Zekai Tahir Burak Women's Health Research and Education Hospital
    Efficacy
    safety
    nasal SIMV
    nasal CPAP
    infants who are >35 gestational week with wet lung
    Additional relevant MeSH terms:
    Tachypnea
    Transient Tachypnea of the Newborn

    Study Results

    No Results Posted as of Dec 26, 2011