Barriers to Recruitment in an Acute Neonatal Seizure Drug Trial: Lessons from a Randomized, Double-Blind, Controlled Study of Intravenous Phenobarbital
Shani Israel
1
,
Courtney Lowe
1
,
Zahr Alkhadem
1
,
Emmeline Roth
2
,
Lindsay Ruffini
1
,
Tammy Tsuchida
1, 3
,
Tayyba Anwar
1, 3
2
Janssen Research and Development, Raritan, New Jersey
|
Publication type: Journal Article
Publication date: 2025-04-01
scimago Q1
wos Q2
SJR: 0.825
CiteScore: 3.9
Impact factor: 2.1
ISSN: 08878994, 18735150
Abstract
BackgroundDespite the prevalence of seizures among neonates, neonatal seizure drug trials are rarely conducted due to ethical considerations, difficulties in trial design, and limited hospital resources and personnel. The purpose of this prospective consecutive case series is to highlight the experiences and challenges encountered by a single study site in participant recruitment for an acute neonatal seizure treatment trial that was active between January 24, 2022, and February 1, 2023.
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Israel S. et al. Barriers to Recruitment in an Acute Neonatal Seizure Drug Trial: Lessons from a Randomized, Double-Blind, Controlled Study of Intravenous Phenobarbital // Pediatric Neurology. 2025. Vol. 165. pp. 74-77.
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Israel S., Lowe C., Alkhadem Z., Roth E., Ruffini L., Tsuchida T., Anwar T. Barriers to Recruitment in an Acute Neonatal Seizure Drug Trial: Lessons from a Randomized, Double-Blind, Controlled Study of Intravenous Phenobarbital // Pediatric Neurology. 2025. Vol. 165. pp. 74-77.
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TY - JOUR
DO - 10.1016/j.pediatrneurol.2025.01.020
UR - https://linkinghub.elsevier.com/retrieve/pii/S0887899425000281
TI - Barriers to Recruitment in an Acute Neonatal Seizure Drug Trial: Lessons from a Randomized, Double-Blind, Controlled Study of Intravenous Phenobarbital
T2 - Pediatric Neurology
AU - Israel, Shani
AU - Lowe, Courtney
AU - Alkhadem, Zahr
AU - Roth, Emmeline
AU - Ruffini, Lindsay
AU - Tsuchida, Tammy
AU - Anwar, Tayyba
PY - 2025
DA - 2025/04/01
PB - Elsevier
SP - 74-77
VL - 165
SN - 0887-8994
SN - 1873-5150
ER -
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@article{2025_Israel,
author = {Shani Israel and Courtney Lowe and Zahr Alkhadem and Emmeline Roth and Lindsay Ruffini and Tammy Tsuchida and Tayyba Anwar},
title = {Barriers to Recruitment in an Acute Neonatal Seizure Drug Trial: Lessons from a Randomized, Double-Blind, Controlled Study of Intravenous Phenobarbital},
journal = {Pediatric Neurology},
year = {2025},
volume = {165},
publisher = {Elsevier},
month = {apr},
url = {https://linkinghub.elsevier.com/retrieve/pii/S0887899425000281},
pages = {74--77},
doi = {10.1016/j.pediatrneurol.2025.01.020}
}