Selective intrauterine growth restriction (sIUGR)
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
2 Years to 17 Years
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. When one of the parents has passed away, the surviving parent with parental authority can provide informed consent. When both parents have passed, guardians or caretakers with parental authority can provide informed consent.
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 |
|---|---|
| To assess long-term neurodevelopmental outcome, cognitive and motor development will be evaluated using standardized psychometric age-appropriate tests and a neurological examination. Echocardiography will be used to assess differences in structural cardiac measures and cardiac function, including aortic pulse-wave velocity (aPWV) and carotid intima-media thickness (cIMT). Spirometry will be recorded in children >= 4 years old to quantify lung function, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and forced mid-expiratory flow rate (FEF(25%-75%). Growth will be assessed using available childhood growth curves from the primary care system and by detailed anthropometric measurements. | — |
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. | — |
Countries
Netherlands
Outcome results
None listed