Outcomes following Extreme Preterm Birth

Patient reported outcomes in adolescents born preterm – insights from telemedicine - PRISMA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58208

Enrollment

200

Registered

2025-07-14

Start date

2026-04-13

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Extreme preterm birth, adolescents, health outcomes Outcomes following extreme preterm birth

Interventions

None listed

Eligibility

Age

12 Years to 17 Years

Inclusion criteria

Inclusion criteria: Preterm groupThe study will include extremely preterm born adolescents, who were admitted to the NICU of the Erasmus MC Sophia Children’s Hospital. Subjects for the present study will meet all of the following criteria:Born between January 2010 and December 2013*Gestational age <28 weeksAge at assessment: 13-16 (including) yearsControl groupBorn between January 2010 and December 2013*Born at full term (=37 weeks’ gestation)Age at assessment between 13-16 years (inclusive)*Can be extended from 2009 to 2014

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Major chromosomal and/or congenital anomaliesInability to comply with the study procedures. 

Design outcomes

Primary

Measure	Time frame
Primary outcomes focus on neurodevelopmental functioning in adolescents born extremely preterm, as assessed through patient-reported outcome measures (PROMs). The main outcome measures for the first research question are the PROM scores and the results from the semi-structured video consultation. These tools are used to identify difficulties across various domains of daily functioning, including emotional, behavioral, and social aspects. Adolescents complete the questionnaires themselves, providing direct insight into their own thinking, abilities, skills and challenges. This self-reported data forms the foundation for evaluating the primary neurodevelopmental outcomes of the study.	—

Measure

Time frame

Primary outcomes focus on neurodevelopmental functioning in adolescents born extremely preterm, as assessed through patient-reported outcome measures (PROMs). The main outcome measures for the first research question are the PROM scores and the results from the semi-structured video consultation. These tools are used to identify difficulties across various domains of daily functioning, including emotional, behavioral, and social aspects. Adolescents complete the questionnaires themselves, providing direct insight into their own thinking, abilities, skills and challenges. This self-reported data forms the foundation for evaluating the primary neurodevelopmental outcomes of the study.

—

Secondary

Measure	Time frame
Secondary outcomes focus on additional dimensions of neurodevelopmental functioning and biological correlates in adolescents born extremely preterm. While the semi-structured video consultation contributes to the primary outcomes, it also provides supplementary qualitative insights alongside assessments of executive functioning and cognitive testing. During the in-person assessment day, intellectual functioning is measured using the Wechsler Intelligence Scale for Children – Fifth Edition (WISC-V), and MRI scans are conducted to evaluate brain structure, connectivity, and maturation. A buccal swab is collected at home to investigate potential biological mechanisms underlying long-term impairments, with particular attention to epigenetic factors. Together, these secondary measures contribute to a more comprehensive understanding of the adolescents’ neurodevelopmental profiles.Additional study parameters include sociodemographic information such as socioeconomic status, parental education and occupation, and other demographic characteristics. Relevant clinical data are also extracted from medical records, including birth weight, gestational age, and neonatal complications such as bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and brain injury.	—

Measure

Time frame

Secondary outcomes focus on additional dimensions of neurodevelopmental functioning and biological correlates in adolescents born extremely preterm. While the semi-structured video consultation contributes to the primary outcomes, it also provides supplementary qualitative insights alongside assessments of executive functioning and cognitive testing. During the in-person assessment day, intellectual functioning is measured using the Wechsler Intelligence Scale for Children – Fifth Edition (WISC-V), and MRI scans are conducted to evaluate brain structure, connectivity, and maturation. A buccal swab is collected at home to investigate potential biological mechanisms underlying long-term impairments, with particular attention to epigenetic factors. Together, these secondary measures contribute to a more comprehensive understanding of the adolescents’ neurodevelopmental profiles.Additional study parameters include sociodemographic information such as socioeconomic status, parental education and occupation, and other demographic characteristics. Relevant clinical data are also extracted from medical records, including birth weight, gestational age, and neonatal complications such as bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and brain injury.

—

Countries

Netherlands

Contacts

Public ContactD Adelmund

Erasmus MC, Universitair Medisch Centrum Rotterdam

onderzoek.neonatologie@erasmusmc.nl0107038649

Outcome results