The University of Southampton
University of Southampton Institutional Repository

Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): challenges of conducting a feasibility trial

Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): challenges of conducting a feasibility trial
Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): challenges of conducting a feasibility trial

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.

Anemia, Sickle Cell, Antisickling Agents, Child, Child, Preschool, Feasibility Studies, Female, Follow-Up Studies, Guideline Adherence, Humans, Hydroxyurea, Male, Middle Cerebral Artery, Nigeria, Pilot Projects, Stroke, Ultrasonography, Doppler, Transcranial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
1545-5017
395-401
Galadanci, Najibah A.
80dec9f8-31bc-4f08-886f-bd4e8477a671
Abdullahi, Shehu U.
16db6610-f79c-467b-804f-2a9f196c7453
Tabari, Musa A.
3ea02890-11e7-4fda-994c-9a3eda13fa9a
Abubakar, Shehi
265e26a5-913d-48dc-bc7a-9824ce4450f3
Belonwu, Raymond
672fa7bc-e7d4-41b0-bd18-6eec42703d10
Salihu, Auwal
b53aac95-0ceb-4f11-90eb-bd257e4144e5
Neville, Kathleen
f072b96f-234e-4152-9456-e6547930a628
Kirkham, Fenella
1dfbc0d5-aebe-4439-9fb2-dac6503bcd58
Inusa, Baba
830cfc6c-2482-4986-b2d3-9edd5cf2d9f5
Shyr, Yu
cc4a2b20-95f5-4329-ac05-27046d025c6a
Phillips, Sharon
4179f31b-f66b-4f25-a1c8-7c9c44f196ac
Kassim, Adetola A.
5cb6d6cb-8ec6-4ffb-b939-f3c10f1599ee
Jordan, Lori C.
a9c77505-fc6e-4ab7-bba2-eed55c93bbb1
Aliyu, Muktar H.
8acd6d5a-d6f7-4560-8fbf-76fd616ef2b7
Covert, Brittany V.
fe5cd779-28e7-4822-93d7-bd2c0b7bc505
DeBaun, Michael R.
76559153-80c6-4642-bdf8-672a75570dfe
Galadanci, Najibah A.
80dec9f8-31bc-4f08-886f-bd4e8477a671
Abdullahi, Shehu U.
16db6610-f79c-467b-804f-2a9f196c7453
Tabari, Musa A.
3ea02890-11e7-4fda-994c-9a3eda13fa9a
Abubakar, Shehi
265e26a5-913d-48dc-bc7a-9824ce4450f3
Belonwu, Raymond
672fa7bc-e7d4-41b0-bd18-6eec42703d10
Salihu, Auwal
b53aac95-0ceb-4f11-90eb-bd257e4144e5
Neville, Kathleen
f072b96f-234e-4152-9456-e6547930a628
Kirkham, Fenella
1dfbc0d5-aebe-4439-9fb2-dac6503bcd58
Inusa, Baba
830cfc6c-2482-4986-b2d3-9edd5cf2d9f5
Shyr, Yu
cc4a2b20-95f5-4329-ac05-27046d025c6a
Phillips, Sharon
4179f31b-f66b-4f25-a1c8-7c9c44f196ac
Kassim, Adetola A.
5cb6d6cb-8ec6-4ffb-b939-f3c10f1599ee
Jordan, Lori C.
a9c77505-fc6e-4ab7-bba2-eed55c93bbb1
Aliyu, Muktar H.
8acd6d5a-d6f7-4560-8fbf-76fd616ef2b7
Covert, Brittany V.
fe5cd779-28e7-4822-93d7-bd2c0b7bc505
DeBaun, Michael R.
76559153-80c6-4642-bdf8-672a75570dfe

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. and DeBaun, Michael R. (2015) Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): challenges of conducting a feasibility trial. Pediatric Blood and Cancer, 62 (3), 395-401. (doi:10.1002/pbc.25289).

Record type: Article

Abstract

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.

Full text not available from this repository.

More information

Accepted/In Press date: 5 September 2014
e-pub ahead of print date: 14 November 2014
Published date: March 2015
Additional Information: © 2014 Wiley Periodicals, Inc.
Keywords: Anemia, Sickle Cell, Antisickling Agents, Child, Child, Preschool, Feasibility Studies, Female, Follow-Up Studies, Guideline Adherence, Humans, Hydroxyurea, Male, Middle Cerebral Artery, Nigeria, Pilot Projects, Stroke, Ultrasonography, Doppler, Transcranial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't

Identifiers

Local EPrints ID: 419544
URI: https://eprints.soton.ac.uk/id/eprint/419544
ISSN: 1545-5017
PURE UUID: 3b6debbc-c8a3-42af-aaa3-3284dcc932b6

Catalogue record

Date deposited: 13 Apr 2018 16:30
Last modified: 13 Mar 2019 18:42

Export record

Altmetrics

Contributors

Author: Najibah A. Galadanci
Author: Shehu U. Abdullahi
Author: Musa A. Tabari
Author: Shehi Abubakar
Author: Raymond Belonwu
Author: Auwal Salihu
Author: Kathleen Neville
Author: Fenella Kirkham
Author: Baba Inusa
Author: Yu Shyr
Author: Sharon Phillips
Author: Adetola A. Kassim
Author: Lori C. Jordan
Author: Muktar H. Aliyu
Author: Brittany V. Covert
Author: Michael R. DeBaun

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×