Long-term Effects of selective fetal growth restriction in MONochorionic twins

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24670

Enrollment

132

Registered

2021-10-27

Start date

2021-01-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selective fetal growth restriction (sFGR), monochorionic twins.

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a subject must meet all the following criteria: • MC twins with sFGR born in the LUMC. • Children aged 2 to 17 years at time of inclusion. • Children currently living in the Netherlands. The parents of a potential subject must meet the following criteria: • Parent(s) aged = 18 years, who are able to consent. • Written informed consent from both parents to participate, form being approved by the Ethic Committee.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • MC twins with TTTS or TAPS. • Twin Reversed Arterial Perfusion (TRAP). • Monoamniotic twin pregnancies. • Children passed away before inclusion. • Single survivors. • Children born with congenital/chromosomal abnormalities.

Design outcomes

Primary

Measure	Time frame
The project addresses five primary objectives: I. To assess long-term neurodevelopmental outcome using cognitive tests II. To assess long-term cardiovascular outcome using cardiac ultrasound III. To assess long-term pulmonary outcome using spirometry IV. To assess long-term growth by evaluating childhood growth patterns V. To assess long-term (epi)genetic changes by evaluating DNA methylation patterns in buccal swabs These outcomes will be examined in a large cohort of MC twins with sFGR and compared between the small and the large twin.	—

Measure

Time frame

The project addresses five primary objectives: I. To assess long-term neurodevelopmental outcome using cognitive tests II. To assess long-term cardiovascular outcome using cardiac ultrasound III. To assess long-term pulmonary outcome using spirometry IV. To assess long-term growth by evaluating childhood growth patterns V. To assess long-term (epi)genetic changes by evaluating DNA methylation patterns in buccal swabs These outcomes will be examined in a large cohort of MC twins with sFGR and compared between the small and the large twin.

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Secondary

Measure	Time frame
The project addresses multiple secondary objectives that can be grouped into the same five categories as the primary objectives: I. Neurodevelopmental outcome a) To describe the incidence of mild and severe NDI. b) To identify potential risk factors within the sFGR population for low cognitive test scores. c) To evaluate long-term behavioral outcome, attachment, quality of life and school functioning including academic performance. II. Cardiovascular outcome a) To assess within-pair differences in blood pressure. III. Pulmonary outcome a) To document within-pair differences in atopic constitution. IV. Growth a) To assess pubertal development. b) To assess intra-twin growth patterns in the sFGR population. V. (Epi)genetics a) To describe epigenetic differences in peripheral tissue (buccal swabs) as a possible underlying mechanism for the mediation of the long-term effects of FGR. The specific DNA methylation patterns found in the Twinlife study will be examined in the population of the current study as well to examine their link with long-term outcomes.	—

Measure

Time frame

The project addresses multiple secondary objectives that can be grouped into the same five categories as the primary objectives: I. Neurodevelopmental outcome a) To describe the incidence of mild and severe NDI. b) To identify potential risk factors within the sFGR population for low cognitive test scores. c) To evaluate long-term behavioral outcome, attachment, quality of life and school functioning including academic performance. II. Cardiovascular outcome a) To assess within-pair differences in blood pressure. III. Pulmonary outcome a) To document within-pair differences in atopic constitution. IV. Growth a) To assess pubertal development. b) To assess intra-twin growth patterns in the sFGR population. V. (Epi)genetics a) To describe epigenetic differences in peripheral tissue (buccal swabs) as a possible underlying mechanism for the mediation of the long-term effects of FGR. The specific DNA methylation patterns found in the Twinlife study will be examined in the population of the current study as well to examine their link with long-term outcomes.

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Contacts

Public ContactSophie Groene

Leiden University Medical Center

s.g.groene@lumc.nl071-5296616

Outcome results