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Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Institute of Child Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00415727
First Posted: December 25, 2006
Last Update Posted: December 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Child Health
  Purpose
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.

Condition Intervention Phase
Sickle Cell Anaemia Device: auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single

Resource links provided by NLM:


Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • Change in processing speed index

Secondary Outcome Measures:
  • 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
  • Change in Blood pressure
  • Number of omissions on Conners Continuous Performance Test
  • Change in Chervin sleep Questionnaire
  • Change in Behaviour Rating Inventory of Executive Function (BRIEF)
  • Change in number of abnormalities (Adams’ criteria) on TCD

Estimated Enrollment: 22
Study Start Date: November 2006
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415727


Contacts
Contact: Fenella Kirkham, Dr f.kirkham@ich.ucl.ac.uk

Locations
United Kingdom
Neuroscience Unit, Institute of Child Health Recruiting
London, United Kingdom, WC1N 1EH
Contact: Fenella Kirkham, Dr       f.kirkham@ich.ucl.ac.uk   
Principal Investigator: Fenella Kirkham, Dr         
Kings College hospital Recruiting
London, United Kingdom, WC2R 2LS
Contact: David Rees, Dr       david.rees@kcl.ac.uk   
Principal Investigator: David Rees, Dr         
Sponsors and Collaborators
Institute of Child Health
Investigators
Principal Investigator: Fenella Kirkham, Dr Institute Of Child Health and Great Ormond Street Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00415727     History of Changes
Other Study ID Numbers: 99NR31
First Submitted: December 22, 2006
First Posted: December 25, 2006
Last Update Posted: December 25, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn