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Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

NCT ID: NCT00415727

Last Updated: 2006-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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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

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

Conditions

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Sickle Cell Anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Interventions

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auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age \>4 years.
2. 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.
3. Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Child Health

OTHER

Sponsor Role lead

Principal Investigators

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Fenella Kirkham, Dr

Role: PRINCIPAL_INVESTIGATOR

Institute Of Child Health and Great Ormond Street Hospital

Locations

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Neuroscience Unit, Institute of Child Health

London, , United Kingdom

Site Status RECRUITING

Kings College hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Fenella Kirkham, Dr

Role: CONTACT

Email: [email protected]

Facility Contacts

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Fenella Kirkham, Dr

Role: primary

David Rees, Dr

Role: primary

Other Identifiers

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99NR31

Identifier Type: -

Identifier Source: org_study_id