Follow-Up after feToscopic sURgical intErventions: the FUTURE study

Completed

Conditions: complicated Monochorionic Monoamniotic twin pregnancies
Fetal/Neonatal Alloimmune Thrombocytopenia
Lower Urinary Tract Obstruction
primary hydrothorax- congenital lung disease
Retinopathy of Prematurity
selective intrauterine growth restriction
the death of a co-twin following Selective Feticide
twin anemia polycythemia sequence
twin-twin-transfusion syndrom
10047060

Registration Number: NL-OMON39565

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 737

Inclusion Criteria

All long-term survivors following fetal therapy for TTTS, Twin Anemia Polycythemia Sequence (TAPS), the death of a co-twin following Selective Feticide, selective Intra Uterine Growth Retardation (sIUGR), Monochorionic Monoamniotic twin pregnancies (MoMo twins), primary hydrothoraces, congenital lung disease, Lower Urinary Tract Obstruction (LUTO) and Fetal/Neonatal Alloimmune Thrombocytopenia (FNAIT).
Children must be at least 2 years of age (corrected for prematurity) to be eligible for the study.

Exclusion Criteria

Parents with no live-born children will be excluded from asking consent for participation.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The incidence of developmental problems: cognitive functioning at least one<br /><br>standard deviation below the mean (test score < 85), mild to moderate motor<br /><br>problems including hearing and vision problems, learning problems, symptoms of<br /><br>pervasive developmental disorder, attention deficit or behavioral problems.<br /><br>2. The incidence of neurodevelopmental impairment: cognitive functioning test<br /><br>score at least two standard deviations below the mean (test score < 70),<br /><br>abnormal neurological outcome including severe motor problems and Cerebral<br /><br>Palsy, bilateral blindness or bilateral deafness requiring amplification.<br /><br>3. Risk factors for developmental problems and neurodevelopmental impairment.<br /><br>4. Health Related Quality of Life of the children.<br /><br>5. Parenting stress levels after fetoscopic surgical intervention.<br /><br>6. ROP-status. </p><br>

Secondary Outcome Measures