The Role of Sustained Inflation on Short Term Respiratory... | NCT03165305

Studies
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants

NCT03165305

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Aug 13, 2019Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Respiratory Distress Syndrome, Newborn
Transient Tachypnea of the Newborn
Respiratory Morbidity

Interventions

Sustained Inflation

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

May 5, 2019Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

May 23, 2017

First Submission Date that Met QC Criteria

May 23, 2017

First Posted Date

May 24, 2017Actual

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

Aug 12, 2019

Last Update Posted Date

Aug 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Merih Cetinkaya, Associate Professor, MD,PhD, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sustained Inflation Group	Experimental	Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery.	Other: Sustained Inflation
No Intervention group	No Intervention	Includes routine neonatal care in the delivery room

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sustained Inflation	Other	Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.	Sustained Inflation Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory Morbidity	RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

term newborns
parental informed consent
inborn infants

Exclusion Criteria:

major congenital/chromosomal abnormalities
lack of informed consent
outborn infants
Premature infants

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Minutes

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merih Cetinkaya	Kanuni Sultan Suleyman Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni Sultan Suleyman Training and Research Hospital		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012127	Respiratory Distress Syndrome, Newborn
D059245	Transient Tachypnea of the Newborn

Ancestor Terms

ID	Term
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided