The TransplantLines Next Generation study is an innovative prospective cohort study aimed at exploring the long-term health implications for offspring born to mothers who have undergone solid organ transplantation (SOT). Although successful pregnancies with healthy newborns have been documented following various types of SOT, there is limited data regarding the long-term health outcomes of these offspring. Factors such as immunosuppressive medication exposure and heightened risk for pregnancy complications underscore the importance of this study.
This research intends to fill the knowledge gap concerning the health statuses of children born post-SOT, especially as health problems related to fetal development may manifest later in life.
The TransplantLines Next Generation study is designed as a descriptive and prospective cohort with biobank elements. It is set to recruit participants aged 16 years and older who were born after kidney transplantation (KTx) or liver transplantation (LiTx). Due to the rarity of pregnancies following pancreas (PTx), heart (HTx), and lung transplantation (LuTx), the study will also include all offspring of any age born after these transplant types within the Netherlands.
Participants will attend a one-time comprehensive study visit, which will include completing questionnaires, undergoing various physical assessments (such as kidney ultrasounds and blood pressure monitoring), and donating biological samples (including urine and blood) for biobanking.
The primary endpoints emphasize assessing cardiovascular and kidney health through a variety of established metrics, and secondary objectives will evaluate immunological status, quality of life, and microbiome composition.
The study population encompasses offspring born to mothers with all forms of SOT, with special attention given to combined transplantations. Eligible participants include individuals born following KTx and/or LiTx aged 16 years and beyond, as well as all offspring of any age born after other forms of organ transplantation in the Netherlands.
To enhance research quality, health outcomes will be compared against reference values and established birth cohorts, including a control group of healthy individuals.
Recruitment for the TransplantLines Next Generation study will be facilitated through recent national studies focused on pregnancies post-KTx, LiTx, HTx, and LuTx. Eligible mothers will be contacted for permission to invite their offspring to participate, with measures taken to ensure informed consent is obtained for all study components.
Participants will undergo an approximate 1.5- to 2-hour study visit, during which they will complete a questionnaire and provide biological samples. Physical examination procedures will include assessments of height, weight, and kidney health. For participants under 16 years of age, modified assessments will ensure compliance with relevant guidelines.
The data collection framework aligns with the TransplantLines Biobank protocols established at the University Medical Center Groningen.
Data management will be conducted using the REDCap electronic data capture platform at UMCG. Primary analytics will focus on cardiovascular health and kidney function, comparing outcomes against established reference values and healthy controls. All results will be interpreted within a framework considering exploratory nature of the findings.
Patient perspectives have played a crucial role in shaping the study through consultations with affected families. Input was gathered during a symposium specifically convened to discuss pregnancy after kidney transplantation. Recommendations from patients and advisory boards have been incorporated into the research design.
Ethical oversight for the study has been granted by the METc UMC Groningen. The investigation conforms to the ethical principles outlined in the Declaration of Helsinki, along with compliance to national regulations regarding research involving human subjects. All participant data will remain confidential, with pseudonymization protocols in place.
Findings from this research are projected to be shared through peer-reviewed journals and presentations at related conferences. The objective is to enhance care protocols for families with pregnancy aspirations following organ transplantation and to provide a basis for future studies.