Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

December 23, 2006 updated by: Institute of Child Health
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 1EH
        • Recruiting
        • Neuroscience Unit, Institute of Child Health
        • Contact:
        • Principal Investigator:
          • Fenella Kirkham, Dr
      • London, United Kingdom, WC2R 2LS
        • Recruiting
        • Kings College Hospital
        • Contact:
        • Principal Investigator:
          • David Rees, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in processing speed index

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Child Health

Investigators

  • Principal Investigator: Fenella Kirkham, Dr, Institute Of Child Health and Great Ormond Street Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Registration Dates

First Submitted

December 22, 2006

First Submitted That Met QC Criteria

December 23, 2006

First Posted (Estimate)

December 25, 2006

Study Record Updates

Last Update Posted (Estimate)

December 25, 2006

Last Update Submitted That Met QC Criteria

December 23, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99NR31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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