Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study

Angret de Boer; André Krom; Rania Kalaai; Marieke de Vries; Marije Hogeveen; Sylvia A. Obermann-Borst; Marijn Vermeulen; M. Beatrijs van der Hout-van der Jagt; Juliette S. van Haren; Peter Andriessen; Martine C. de Vries; Rosa Geurtzen; E. J. T. Verweij

doi:10.1111/1471-0528.18189

Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study

Angret de Boer, André Krom, Rania Kalaai, Marieke de Vries, Marije Hogeveen, Sylvia A. Obermann-Borst, Marijn Vermeulen, M. Beatrijs van der Hout-van der Jagt, Juliette S. van Haren, Peter Andriessen, Martine C. de Vries, Rosa Geurtzen, E. J. T. Verweij

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Journal	BJOG : An International Journal of Obstetrics and Gynaecology
Volume	XX
Issue number	X
DOIs	https://doi.org/10.1111/1471-0528.18189
Publication status	E-pub ahead of print - 29 Apr 2025

Funding

This work was funded by the ZonMw Clinical Fellow programme (90719039) and partially supported by a research grant from the European Society for Paediatric Research (RGP2022\u2010EPDRG\u201004/04). Funding:

Keywords

ectogenesis
ethics
extremely premature infant
foetal viability
neonatology
parents
perinatal care
placenta
qualitative research
technology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1111/1471-0528.18189

Cite this

de Boer, A., Krom, A., Kalaai, R., de Vries, M., Hogeveen, M., Obermann-Borst, S. A., Vermeulen, M., van der Hout-van der Jagt, M. B., van Haren, J. S., Andriessen, P., de Vries, M. C., Geurtzen, R., & Verweij, E. J. T. (2025). Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study. BJOG : An International Journal of Obstetrics and Gynaecology, XX(X). Advance online publication. https://doi.org/10.1111/1471-0528.18189

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title = "Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study",

abstract = "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.",

keywords = "ectogenesis, ethics, extremely premature infant, foetal viability, neonatology, parents, perinatal care, placenta, qualitative research, technology",

author = "{de Boer}, Angret and Andr{\'e} Krom and Rania Kalaai and {de Vries}, Marieke and Marije Hogeveen and Obermann-Borst, {Sylvia A.} and Marijn Vermeulen and {van der Hout-van der Jagt}, {M. Beatrijs} and {van Haren}, {Juliette S.} and Peter Andriessen and {de Vries}, {Martine C.} and Rosa Geurtzen and Verweij, {E. J. T.}",

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month = apr,

day = "29",

doi = "10.1111/1471-0528.18189",

language = "English",

volume = "XX",

journal = "BJOG : An International Journal of Obstetrics and Gynaecology",

issn = "1470-0328",

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de Boer, A, Krom, A, Kalaai, R, de Vries, M, Hogeveen, M, Obermann-Borst, SA, Vermeulen, M, van der Hout-van der Jagt, MB , van Haren, JS , Andriessen, P, de Vries, MC, Geurtzen, R & Verweij, EJT 2025, 'Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study', BJOG : An International Journal of Obstetrics and Gynaecology, vol. XX, no. X. https://doi.org/10.1111/1471-0528.18189

TY - JOUR

T1 - Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology

T2 - A Qualitative Study

AU - de Boer, Angret

AU - Krom, André

AU - Kalaai, Rania

AU - de Vries, Marieke

AU - Hogeveen, Marije

AU - Obermann-Borst, Sylvia A.

AU - Vermeulen, Marijn

AU - van der Hout-van der Jagt, M. Beatrijs

AU - van Haren, Juliette S.

AU - Andriessen, Peter

AU - de Vries, Martine C.

AU - Geurtzen, Rosa

AU - Verweij, E. J. T.

PY - 2025/4/29

Y1 - 2025/4/29

N2 - 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.

AB - 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.

KW - ectogenesis

KW - ethics

KW - extremely premature infant

KW - foetal viability

KW - neonatology

KW - parents

KW - perinatal care

KW - placenta

KW - qualitative research

KW - technology

UR - http://www.scopus.com/inward/record.url?scp=105004188666&partnerID=8YFLogxK

U2 - 10.1111/1471-0528.18189

DO - 10.1111/1471-0528.18189

M3 - Article

C2 - 40302112

SN - 1470-0328

VL - XX

JO - BJOG : An International Journal of Obstetrics and Gynaecology

JF - BJOG : An International Journal of Obstetrics and Gynaecology

IS - X

ER -

Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study

Abstract

Funding

Keywords

UN SDGs

Access to Document

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Perinatal Medicine

Cite this

Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study

Abstract

Funding

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Research areas

Perinatal Medicine

Cite this