Prevention Of Morbidity In Sickle Cell Disease Pilot Phase | NCT00415727

Studies
Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

NCT00415727

Sponsor

Institute of Child Health

Status

Unknown status

Last Update Posted

Dec 25, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Sickle Cell Anaemia

Interventions

auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation

Countries

United Kingdom

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 2006

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

Nov 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 22, 2006

First Submission Date that Met QC Criteria

Dec 23, 2006

First Posted Date

Dec 25, 2006Estimated

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 23, 2006

Last Update Posted Date

Dec 25, 2006Estimated

Description Module

Brief Summary

The hypothesis is that in sickle cell anaemia, nocturnal oxyhaemoglobin desaturation, is associated with low processing speed index, and this morbidity can be reduced with overnight auto Continuous Positive Airways Pressure and/or oxygen supplementation.

Detailed Description

Intervention: Overnight auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation if mean overnight oxyhaemoglobin saturation is not >94% after 2 weeks of autoCPAP

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in processing speed index

Secondary Outcomes

Measure	Description	Time Frame
Frequency of pain measured via SMS and pain diary
Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >4 years.
Informed consent with assent in accordance with UK ethical committee(COREC) system must be signed by the patient's parent or legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study.
Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fenella Kirkham, Dr	Contact			f.kirkham@ich.ucl.ac.uk

Overall Officials

Name	Affiliation	Role
Fenella Kirkham, Dr	Institute Of Child Health and Great Ormond Street Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neuroscience Unit, Institute of Child Health	Recruiting	London		WC1N 1EH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D045422	Continuous Positive Airway Pressure

Ancestor Terms

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided