Effects of Intraoperative Oxygen Therapy on Oxygenation o... | NCT02804555

Studies
Effects of Intraoperative Oxygen Therapy on Oxygenation of Newborns Born Via Elective Cesarian Section

NCT02804555

Sponsor

Szeged University

Status

Completed

Last Update Posted

Apr 27, 2017Actual

Enrollment

107Actual

Phase

Not Applicable

Conditions

Obstetrical Complication of Anesthesia

Interventions

Oxygen

Countries

Hungary

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

Nov 2016

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

Jun 2013

Primary Completion Date

Jun 2016Actual

Completion Date

Nov 30, 2016Actual

First Submitted Date

Jun 6, 2016

First Submission Date that Met QC Criteria

Jun 14, 2016

First Posted Date

Jun 17, 2016Estimated

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

Apr 26, 2017

Last Update Posted Date

Apr 27, 2017Actual

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

In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial artery in parallel with umbilical clamping and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a properly equipped laboratory.

Detailed Description

Whole-blood superoxide and hydrogen peroxide production was measured from the newborn's umbilical chord.

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

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxygen support	Active Comparator	5 liter / minute oxygen has given to the mothers on face mask.	Other: Oxygen
Room air	No Intervention	Oxygen support has not given to the mothers.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygen	Other	Oxygen administration	Oxygen support

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hyperoxia Newborns	We measured umbilical vein blood gas parameters.	through study completion up to two years

Secondary Outcomes

Measure	Description	Time Frame
Maternal hyperoxia	We measured arterial blood gas parameters of the mother from radial artery.	through study completion up to two years
Alterations in newborns' enzyme functions due to maternal hyperoxia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective cesarean section.
Signed informed consent form.

Exclusion Criteria:

Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zsolt Molnar, MD	Szeged University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology and Intensive Therapy		Szeged	Csongrád megye	6725	Hungary

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010100	Oxygen

Ancestor Terms

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases

Browse Leaves

Not provided

Browse Branches

Not provided