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Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals’ and parental perspectives

Pediatric Research volume 98, pages 2385–2393 (2025)Cite this article

Abstract

Background

The Artificial Amnion and Placenta Technology (AAPT) is developed to improve outcomes of extremely premature birth, with first in-human trials expected in the coming years. Empirical research with key stakeholders is essential for responsibly designing these trials. This study aims to discuss considerations for counselling and informed consent for the first in-human trials of the AAPT, discussing legal and ethical considerations.

Methods

A qualitative study using both individual and focus group interviews with healthcare professionals (HCPs) and parents was performed. Interviews were thematically analysed.

Results

Fifteen parents and 46 HCPs were interviewed. The results are represented into key themes reflecting participants’ perspectives on: (I) the moral and legal status of the subject treated in AAPT trials, (II) the first participant: the pregnant person, and (III) the terminology used to describe the technology. Furthermore, considerations around the informed consent process and counselling, including parental hope, are described. The findings suggest these factors are interconnected, as the moral and legal context surrounding AAPT trials influences the approach to counselling and informed consent.

Conclusion

Resolving key ethical and legal issues important for counselling and informed consent is essential for establishing parental right and the development of a responsible, ethically sound informed consent process.

Impact

  • Addressing ethical and legal issues surrounding counseling and informed consent is essential to safeguard a responsible and ethically sound consent process for future human artificial amnion and placenta technology (AAPT)-trials.

  • This is the first study exploring stakeholder perspectives on the AAPT, highlighting the complexities in counselling and informed consent, such as the moral status of participants and the rights of all parties, which must be carefully navigated before trial designs can progress.

  • The article underscores the importance of establishing consensus and maintaining open dialogue among all stakeholders to create a robust, ethically grounded framework for informed consent in future trials.

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Fig. 1
Fig. 2: An overview of the different consent pathways, including, in grey, the pathway that was not discussed by the participants but could theoretically be an option in the context of ‘nothing to lose’.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

We would like to extend our sincere thanks to all the participants of this study for their time, insights and contributions. We are especially grateful to Leonie Lof and Heidi Theeuwen, who took the time to read the last version of the manuscript and refine the results, and to Lien De Proost, who executed the study. Furthermore, we would like to express our gratitude to the Dutch neonatal patient organization Care4Neo for their valuable support in revising our research protocol, their assistance in recruiting participants for this study, and writing this manuscript. Care4Neo aims to increase knowledge, awareness, and understanding for parents who have a baby that needs to be placed in an incubator and the infant itself. This work was supported by a research grant from the European Society for Pediatric Research (ESPR) provided to R. Geurtzen (RGP2022-EPDRG-04/04). EJTV was funded by the ZonMw Clinical Fellow program (90719039). The other authors received no additional funding. The funders had no role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish.

Author information

Authors and Affiliations

  1. Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands

    Angret de Boer & E. J. T. Verweij

  2. Department of Neonatology, Radboudumc Amalia Children’s Hospital, Nijmegen, The Netherlands

    Angret de Boer, Rania Kalaai, Marije Hogeveen & Rosa Geurtzen

  3. Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, The Netherlands

    André Krom & Martine C. de Vries

  4. Institute for Computing and Information Sciences (iCIS), Radboud University, Nijmegen, The Netherlands

    Marieke de Vries

  5. Care4Neo, Neonatal patient and parent advocacy organization, Rotterdam, The Netherlands

    Sylvia A. Obermann-Borst & Marijn Vermeulen

  6. Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Sophia Children’s Hospital, Erasmus MC, Rotterdam, The Netherlands

    Marijn Vermeulen

  7. Department of Industrial Design, Eindhoven University of Technology, Eindhoven, The Netherlands

    Juliette S. van Haren

  8. Department of Neonatology, Máxima Medical Center, Veldhoven, The Netherlands

    Peter Andriessen

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Contributions

Angret de Boer, MD, took part in designing the study, collected the data through focus groups and individual interviews, carried out the initial analyses of the data and wrote the initial draft of the manuscript. Drs. de Boer had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr. André Krom made a significant contribution to the design of the study, took part in the collection of the data, made a substantial contribution to the analyses and interpretation of the data by participating in the discussions about the data, and reviewed and revised the manuscript. Rania Kalaai was present with the collection of the data and carried out the initial analyses together with drs. de Boer and reviewed the manuscript. Prof. dr. Martine de Vries, dr. Marieke de Vries and dr. Marije Hogeveen took part in the design of the study and collection of data, made a substantial contribution to the analyses and interpretation of the data by participating in the discussions about the data, and critically reviewed and revised the manuscript in multiple rounds of feedback. Dr. Sylvia A. Obermann-Borst and Dr. Marijn Vermeulen made a contribution to revising our research protocol, assisted in recruiting participants for this study, and critically reviewed and revised the manuscript. Dr. Juliette S. van Haren was present with the collection of the data and presented the prototypes of the AAPT during the interviews, critically reviewed and revised the manuscript in multiple rounds of feedback. Dr. Peter Andriessen critically reviewed and revised the manuscript in multiple rounds of feedback. Dr. Joanne Verweij and Dr. Rosa Geurtzen conceptualized and designed the study, contributed to and supervised the analyses of the collected data, and critically reviewed and revised the manuscript. Angret de Boer, MD, is the guarantor of the overall content. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.

Corresponding author

Correspondence to Rosa Geurtzen.

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de Boer, A., Krom, A., Kalaai, R. et al. Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals’ and parental perspectives. Pediatr Res 98, 2385–2393 (2025). https://doi.org/10.1038/s41390-025-04051-8

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