So You Want to Give Stem Cells to Babies? Neonatologists and Parents' Views to Optimize Clinical Trials.
J Pediatr
; 210: 41-47.e1, 2019 07.
Article
em En
| MEDLINE
| ID: mdl-31005276
ABSTRACT
OBJECTIVE:
To identify barriers and enablers that may influence parents' and neonatologists' participation in clinical trials of mesenchymal stromal cells for bronchopulmonary dysplasia. STUDYDESIGN:
This qualitative study involved one-on-one semistructured interviews with parents of extremely preterm infants (n = 18) and neonatologists (n = 16). Interview guides and directed content analysis were framed using the theoretical domains framework, a tool specifically developed for implementation research to identify influences on behavior.RESULTS:
Key barriers for parents included their lack of knowledge about clinical trial processes in general, stem cells, and concerns about their risks and side effects. Importantly, parents preferred to be approached for recruitment directly by a neonatologist, either before delivery or 1 or 2 weeks after birth. However, the majority of neonatologists felt that approaching parents was not part of their role. Neonatologists reported competing priorities, time commitment, costs, and lack of institutional support as significant barriers to their ability to recruit patients.CONCLUSIONS:
By integrating stakeholders early into the development of a clinical trial of mesenchymal stromal cell therapy, we identified and can address important barriers to enrollment. Some identified barriers were unanticipated and could have compromised recruitment had they not been identified by this study. We suggest that this approach can be used more broadly for other early phase clinical trials in pediatrics.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Pais
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Displasia Broncopulmonar
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Atitude do Pessoal de Saúde
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Atitude Frente a Saúde
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Ensaios Clínicos como Assunto
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Transplante de Células-Tronco Mesenquimais
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Neonatologia
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article