Paracetamol Hypothermia Children | NCT04608669

Studies
Paracetamol Hypothermia Children

NCT04608669

Sponsor

Saint George Hospital

Status

Completed

Last Update Posted

Mar 18, 2021Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Safety Issues

Interventions

Paracetamol

Countries

Lebanon

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

Mar 2021

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

Jul 1, 2019Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Sep 30, 2020Actual

First Submitted Date

Oct 24, 2020

First Submission Date that Met QC Criteria

Oct 24, 2020

First Posted Date

Oct 29, 2020Actual

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

Mar 17, 2021

Last Update Posted Date

Mar 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Temperature comparison	Other		Drug: Paracetamol
No change	Active Comparator		Drug: Paracetamol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paracetamol	Drug	Give paracetamol or placebo and compare temperature	No change Temperature comparison

Measure	Description	Time Frame
Temperature variation		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Georges hospital		Beirut			Lebanon

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided