Status:
UNKNOWN
The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years
Lead Sponsor:
Noordwest Ziekenhuisgroep
Conditions:
Preterm Birth
Developmental Delay
Eligibility:
All Genders
9-9 years
Phase:
NA
Brief Summary
Objective of the study: To examine cognition, motor function, executive functions, speech and language development, behaviour, psychosocial functioning,academic achievement, physical morbidities and ...
Detailed Description
SUMMARY Rationale: Recent studies indicate that moderate and late preterm infants (MLPTI, gestational age (GA) 32-36 weeks) are at risk of lower IQ scores, behavioural and attention problems and acade...
Eligibility Criteria
Inclusion
- 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.
- Both parents of the participant have given informed consent for the participation of the study.
Exclusion
- 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
Key Trial Info
Start Date :
August 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05990582
Start Date
August 6 2023
End Date
December 1 2025
Last Update
August 14 2023
Active Locations (1)
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1
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands, 1815JD