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

December 21, 2011 updated by: Gamze Demirel, Zekai Tahir Burak Women's Health Research and Education Hospital
The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Zekai Tahir Burak Maternity Teaching Hospital
        • Contact:
      • Ankara, Turkey
        • Recruiting
        • Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 hours to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >35 gestational week
  • wetlung

Exclusion Criteria:

  • major congenital anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of respiratory support, respiratory insufficiency
Time Frame: 3 months
pneumothorax
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

December 26, 2011

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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