NCT05990582Completed
The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years
Neurodevelopmental Outcomes and Morbidities of Moderate and Late Preterm Children at the Age of 9 Years -The Alkmaar MLPTI Cohort Study
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
Objective of the study: To examine cognition, motor function, executive functions, speech and language development, behaviour, psychosocial functioning,academic achievement, physical morbidities and growth of MLPTI at the age of 9 years and correlate this with BSID-III-NL scores,growth parameters and body composition at the age of 2 years. Study design: This study will be a prospective open, non-therapeutic exploratory cohort study and can be seen as a continuation on the study with protocol identification number NL50800.094.14, performed in the NWZ Alkmaar between 2014 and 2016. This was a study on growth and neurodevelopment of MLPTI in the first 2 years of life. Study population: The study population is a group of 200 moderate and late preterm children who were born in the NWZ Alkmaar between 2014 and 2016. 100 of these children participated in the aforementioned study on growth and neurodevelopment at the age of 2 years. The oldest children in this group will reach the age of 9 years in 2023. Brothers/sisters/friends of these children aged between 8 and 10 will be asked as control group and also 9 year old children who are living in the area of Alkmaar (\< 20 km) and who are invited by the GGD to receive vaccinations at the age of 9 years old or 9 year old children of employees of Noordwest Hospital and all born at full term. (n=70). Primary study parameters/outcome of the study: The main study parameters are the IQ-scores of the WISC-V, the motoric scores of the Movement-ABC, the executive functions of the EMMA Toolbox, the presence of morbidities, the growth pattern and the mean blood pressure at 9 years of age. Secondary study parameters/outcome of the study: Secondary outcome parameters are the he behavioural and psychosocial outcomes of the CBCL and the SDQ scores, speech-and language-developmental scores of the CELF-5-NL and CCC-2-NL, MCH Feeding Scale and Teacher Report Form (TRF) scores. Other outcome parameters are the relation between the 9-year outcomes and the BSID-III scores at the age of 2, and the differences between the MLPTI and the control group. Furthermore, we aim to determine the relation between growth and body composition in the first two years of life and the waist circumference, growth parameters and blood pressure at the age of 9 years.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 153 (actual)
- First submitted
- 25 Jul 2023
- Start date
- 11 Aug 2023
- Primary completion date
- 4 Jul 2026
- Lead sponsor
- Noordwest Ziekenhuisgroep
- NCT number
- NCT05990582
What you commit to
- Study type: Interventional
- Participants enrolled: 153
- From 11 Aug 2023 to the primary completion date, 4 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- In order to be eligible to participate in this study, a subject must meet all the following criteria:
- The participant is born in or transferred to the NWZ Alkmaar between January 1st, 2014 and April 18th, 2016 (the time in which the participants of trial NL50800.094.14 were born).
- The participant born at a gestational age from 32 to 35+6 weeks.
- Both parents of the participant have given informed consent to participate in the 9 years trial
- In order to be eligible to participate in the control group of this study, a subject must meet all the following criteria:
- The participant is 9 years old when participating in this study and is a friend or classmate of the included MLPTI or has visited a GGD site for the 9 years vaccination and is willing to participate or is a (grand)child of an employee of Noordwest Hospital and is living in the area of Alkmaar (\< 20 km).
- Both parents of the participant have given informed consent for the participation of the study.
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- The participant's parents are not able to fill out questionnaires or perform tests in Dutch.
- The participant has a severe developmental or genetic disorder and is thereby not able to perform the tests.
- The participant is not able to come to the outpatient clinic to do the tests.
- A potential subject who meets any of the following criteria will be excluded from participation in this study as part of the control group:
- The participant is born with a GA \< 37 weeks.
- The participant has a severe developmental or genetic disorder and is thereby not able to perform the tests.
- The participant had complications after birth (e.g. admission at a Neonatal ward)
- The participant needs special education
Age in the registry: 9 years to 9 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest Ziekenhuisgroep Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.