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

NCT ID: NCT01499238

Last Updated: 2011-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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

Conditions

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Transient Tachypnea of Newborn

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nasal SIMV

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

Group Type ACTIVE_COMPARATOR

Nasal SIMV

Intervention Type DEVICE

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

nasal CPAP

PEEP: 4-6 mmHg, Fio2: 40%

Group Type ACTIVE_COMPARATOR

nasal CPAP

Intervention Type DEVICE

PEEP: 4-6 mmHg, FİO2: 40%

Interventions

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Nasal SIMV

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

Intervention Type DEVICE

nasal CPAP

PEEP: 4-6 mmHg, FİO2: 40%

Intervention Type DEVICE

Other Intervention Names

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nasal SIMV, SLE 5000 NASAL CPAP, SLE 5000

Eligibility Criteria

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Inclusion Criteria

* \>35 gestational week
* wetlung

Exclusion Criteria

* major congenital anomalies
Minimum Eligible Age

2 Hours

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gamze Demirel

Zekai Tahir Burak Maternity Teaching Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gamze Demirel, MD

Role: PRINCIPAL_INVESTIGATOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Locations

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Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gamze Demirel, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Gamze Demirel, MD

Role: primary

Gamze Demirel, MD

Role: primary

Other Identifiers

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4

Identifier Type: -

Identifier Source: org_study_id