Related Experiment Videos
So You Want to Give Stem Cells to Babies? Neonatologists and Parents' Views to Optimize Clinical Trials
Mireille Guillot1, Sarah Asad2, Manoj M Lalu3
1Department of Pediatrics, Division of Neonatology, Children's Hospital of Eastern Ontario and The Ottawa Hospital, Ottawa, Ontario, Canada.
Insights
Parents and neonatologists face barriers to clinical trial participation for mesenchymal stromal cells in bronchopulmonary dysplasia. Early stakeholder integration is key to addressing these enrollment challenges.
Area of Science:
- Regenerative Medicine
- Neonatal Research
- Clinical Trial Design
Background:
- Bronchopulmonary dysplasia (BPD) is a chronic lung disease affecting preterm infants.
- Mesenchymal stromal cells (MSCs) are being investigated as a potential therapy for BPD.
- Effective clinical trial participation is crucial for advancing MSC therapy for BPD.
Purpose of the Study:
- To identify barriers and enablers influencing parental and neonatologist participation in MSC clinical trials for BPD.
- To inform the design of future pediatric clinical trials.
Main Methods:
- Qualitative study utilizing semistructured interviews.
- Participants included parents of extremely preterm infants (n=18) and neonatologists (n=16).
- Theoretical Domains Framework guided interview content analysis.
Main Results:
- Parental barriers: lack of knowledge about trials, stem cells, and safety concerns.
- Parental preference: direct approach by neonatologists for recruitment.
- Neonatologist barriers: perceived role limitations, competing priorities, time, costs, and institutional support.
Conclusions:
- Early integration of stakeholders (parents, neonatologists) is essential for identifying and addressing clinical trial enrollment barriers.
- Unanticipated barriers can compromise recruitment if not identified early.
- This stakeholder-integrated approach can be applied to other early-phase pediatric clinical trials.
Objective:
To identify barriers and enablers that may influence parents' and neonatologists' participation in clinical trials of mesenchymal stromal cells for bronchopulmonary dysplasia.
Study Design:
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.