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Status unknownNCT00415727Updated Dec 25, 2006

Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

A Phase 2 interventional study of auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation in Sickle Cell Anaemia, sponsored by Institute of Child Health. Status unknown at 2 sites in United Kingdom. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2006-12-25.

Sponsored by Institute of Child Health · Phase 2 and Interventional

The sponsor has not verified this record recently (last verified Dec 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
4 Years to 16 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Sickle Cell Anaemia

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03

In context

Anemia, Sickle Cell

1,104 studies on the registry are indexed under Anemia, Sickle Cell; 236 are open to participants now.

This study's enrollment of 22 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Institute of Child Health is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All

Eligibility 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.
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Single group
Masking
Single
Enrollment
22 participants

Interventions

  • Deviceauto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation
06

What researchers measure

Primary outcomes

  1. Change in processing speed index

Secondary outcomes

  1. Frequency of pain measured via SMS and pain diary

  2. Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count

  3. Change in Blood pressure

  4. Number of omissions on Conners Continuous Performance Test

  5. Change in Chervin sleep Questionnaire

  6. Change in Behaviour Rating Inventory of Executive Function (BRIEF)

  7. Change in number of abnormalities (Adams' criteria) on TCD

07

Study locations

2 of 2 sites recruiting
  • Neuroscience Unit, Institute of Child Health
    London, WC1N 1EH, United Kingdom
    Recruiting
  • Kings College hospital
    London, WC2R 2LS, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 25, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00415727
Lead sponsor
Institute of Child Health
First posted
Dec 25, 2006
Start date
Nov 2006
Last update
Dec 25, 2006

Study contacts

Fenella Kirkham, Dr
Contact
f.kirkham@ich.ucl.ac.uk
Fenella Kirkham, Dr
principal investigator · Institute Of Child Health and Great Ormond Street Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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