Comparison of Nasal CPAP and Nasal SIMV in Transient Tach... | NCT01499238

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

NCT01499238

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Status

Unknown status

Last Update Posted

Dec 26, 2011Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Transient Tachypnea of Newborn

Interventions

Nasal SIMV
nasal CPAP

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Feb 2012Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Dec 14, 2011

First Submission Date that Met QC Criteria

Dec 21, 2011

First Posted Date

Dec 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2011

Last Update Posted Date

Dec 26, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gamze Demirel, Zekai Tahir Burak Maternity Teaching Hospital, Zekai Tahir Burak Women's Health Research and Education HospitalPrincipal Investigator

Lead Sponsor

Zekai Tahir Burak Women's Health Research and Education HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nasal SIMV	Active Comparator	rate: 30-50/min, PIP: 16, PEEP: 4-6, fİO2: 40%	Device: Nasal SIMV
nasal CPAP	Active Comparator	PEEP: 4-6 mmHg, Fio2: 40%	Device: nasal CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasal SIMV	Device	rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%	nasal SIMV

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>35 gestational week
wetlung

Exclusion Criteria:

major congenital anomalies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Hours

Maximum Age

3 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gamze Demirel, MD	Contact			kgamze@hotmail.com

Overall Officials

Name	Affiliation	Role
Gamze Demirel, MD	Zekai Tahir Burak Women's Health Research and Education Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zekai Tahir Burak Maternity Teaching Hospital	Recruiting	Ankara	Ankara		Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D059245	Transient Tachypnea of the Newborn

Ancestor Terms

ID	Term
D012127	Respiratory Distress Syndrome, Newborn
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided