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

Primary Purpose

Transient Tachypnea of Newborn

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Nasal SIMV
nasal CPAP
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Tachypnea of Newborn focused on measuring Efficacy, safety, nasal SIMV, nasal CPAP, infants who are >35 gestational week with wet lung

Eligibility Criteria

2 Hours - 3 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >35 gestational week
  • wetlung

Exclusion Criteria:

  • major congenital anomalies

Sites / Locations

  • Zekai Tahir Burak Maternity Teaching Hospital, Division of NeonatologyRecruiting
  • Zekai Tahir Burak Maternity Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

nasal SIMV

nasal CPAP

Arm Description

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

PEEP: 4-6 mmHg, Fio2: 40%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications of respiratory support, respiratory insufficiency
pneumothorax

Full Information

First Posted
December 14, 2011
Last Updated
December 21, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01499238
Brief Title
Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn
Official Title
Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.
Detailed Description
We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are >35 gestational week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea of Newborn
Keywords
Efficacy, safety, nasal SIMV, nasal CPAP, infants who are >35 gestational week with wet lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nasal SIMV
Arm Type
Active Comparator
Arm Description
rate: 30-50/min, PIP: 16, PEEP: 4-6, fİO2: 40%
Arm Title
nasal CPAP
Arm Type
Active Comparator
Arm Description
PEEP: 4-6 mmHg, Fio2: 40%
Intervention Type
Device
Intervention Name(s)
Nasal SIMV
Other Intervention Name(s)
nasal SIMV, SLE 5000
Intervention Description
rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%
Intervention Type
Device
Intervention Name(s)
nasal CPAP
Other Intervention Name(s)
NASAL CPAP, SLE 5000
Intervention Description
PEEP: 4-6 mmHg, FİO2: 40%
Primary Outcome Measure Information:
Title
efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications of respiratory support, respiratory insufficiency
Description
pneumothorax
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Hours
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >35 gestational week wetlung Exclusion Criteria: major congenital anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze Demirel, MD
Email
kgamze@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
Email
kgamze@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze Demirel, MD
Email
kgamze@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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