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Published on: November 28, 2019
Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A
Angret de Boer1,2, André Krom3, Rania Kalaai2
1Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands.
Insights
Insights from parents and healthcare professionals are crucial for designing responsible human trials of Artificial Amnion and Placenta Technology (AAPT) for extreme prematurity. Key considerations include trial goals, participant selection, and clear success criteria for AAPT.
Area of Science:
- Neonatal care and reproductive technologies.
- Medical device development and clinical trial design.
Background:
- Artificial Amnion and Placenta Technology (AAPT) shows promise in animal models for improving outcomes in extreme prematurity.
- Human trials for AAPT are anticipated, necessitating careful planning.
Purpose of the Study:
- To gather insights from parents of extremely premature infants and healthcare professionals (HCPs) to inform the responsible design of future human AAPT trials.
- To identify essential considerations for conducting human AAPT trials from stakeholder perspectives.
Main Methods:
- A qualitative study involving 15 parents and 46 HCPs who experienced or managed extremely premature births.
- Data collected through eight focus group and five individual interviews.
- Thematic analysis of transcribed interviews.
Main Results:
- Six critical themes emerged: optimizing animal models, defining trial goals, establishing the research population, formulating stop/success criteria and outcome measures, defining the parental role, and developing trial protocols and logistics.
- Stakeholder input identified key areas for responsible trial design.
Conclusions:
- Stakeholder involvement is vital for the responsible design of human AAPT trials.
- Clearly defining trial objectives, including stop criteria and follow-up, is essential.
- Achieving consensus among stakeholders promotes aligned expectations and engagement for successful AAPT trials.
Objective:
Artificial Amnion and Placenta Technology (AAPT), designed to improve outcomes in extreme prematurity, has shown promise in animal studies, with human trials anticipated soon. This study seeks to inform the responsible design of future trials by utilising insights from parents who experienced an (imminent) extremely premature birth and perinatal healthcare professionals (HCPs).
Design:
A qualitative study using individual and focus group interviews.
Setting:
This study was part of a Dutch study called Toward Individualised care of the Youngest.
Sample:
Fifteen parents who experienced an (imminent) extremely premature birth and 46 HCPs were interviewed.
Methods:
Eight focus-group and five individual interviews were performed and transcribed. The transcripts were thematically analysed.
Main Outcomes And Measures:
The perspectives of HCPs and experienced parents on what they considered essential for human AAPT trials.
Results:
Analyses revealed some critical considerations represented in six themes: (1) optimise the animal model, (2) determine the goal of human trials, (3) carefully establish the research population, (4) formulate stop criteria, success criteria and outcome measures, (5) determine the role for parents during the AAPT trial, and (6) develop protocols for the trial and address logistical considerations.
Conclusion:
This study emphasises the critical role of stakeholder involvement in safeguarding the responsible design of human AAPT trials. Defining the trial objectives including well-defined stop criteria and follow-up schemes is a key element for the human AAPT trials. Establishing consensus among stakeholders is essential, as shared recommendations will facilitate alignment of expectations and promote engagement.
