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Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): Challenges of conducting a feasibility trial
Author(s) -
Galadanci Najibah A.,
Abdullahi Shehu U.,
Tabari Musa A.,
Abubakar Shehi,
Belonwu Raymond,
Salihu Auwal,
Neville Kathleen,
Kirkham Fenella,
Inusa Baba,
Shyr Yu,
Phillips Sharon,
Kassim Adetola A.,
Jordan Lori C.,
Aliyu Muktar H.,
Covert Brittany V.,
DeBaun Michael R.
Publication year - 2015
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.25289
Subject(s) - medicine , clinical trial , transcranial doppler , stroke (engine) , adverse effect , placebo , pediatrics , randomized controlled trial , disease , clinical research , alternative medicine , pathology , mechanical engineering , engineering
Background The majority of children with sickle cell disease (SCD), approximately 75%, are born in sub‐Saharan Africa. For children with elevated transcranial Doppler (TCD) velocity, regular blood transfusion therapy for primary stroke prevention is standard care in high income countries, but is not feasible in sub‐Saharan Africa. Procedure In the first U.S. National Institute of Health (NIH) sponsored SCD clinical trial in sub‐Saharan Africa, we describe the protocol and challenges unique to starting a clinical trial in this region. We are conducting a single arm pilot trial of hydroxyurea therapy in children with TCD velocity ≥200 cm/sec in the middle cerebral arteries. Eligible children will be placed on hydroxyurea (n = 40) and followed for 3 years at Aminu Kano Teaching Hospital, Nigeria. Adherence will be measured via the Morisky Scale and adverse events will be determined based on hospitalization. Results Originally, a randomized placebo trial was planned; however, placebo was not approved by the local Ethics Committee. Hence a single arm trial of hydroxyurea will be conducted and five controls per patient with normal TCD measurements will be followed to compare the rate of adverse events to those with abnormal TCD measurements taking hydroxyurea. Using non‐NIH funding, over 9 months, multiple face‐to‐face investigator meetings were conducted to facilitate training. Conclusion A hydroxyurea trial (NCT01801423) for children with SCD is feasible in sub‐Saharan Africa; however, extensive training and resources are needed to build a global patient oriented multi‐disciplinary research team with a common purpose. Pediatr Blood Cancer 2015;62:395–401. © 2014 Wiley Periodicals, Inc.