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Search / Trial NCT05990582

The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years

Launched by NOORDWEST ZIEKENHUISGROEP · Aug 6, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Moderate And Late Preterm Infants Neurodevelopmental Outcomes Growth Morbidities

ClinConnect Summary

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 academic underachievement at the age of 6 to 10 years. These recent findings of impaired outcomes above the age of 6 contrast with earlier studies that suggested that outcomes of MLPTI are comparable to those of full-term children. However, since the number of studies performed on MLPTI above 6 years of age is limited and show different results, the developmental outcomes of MLPTI remains a subject ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Noordwest Ziekenhuisgroep

Noordwest Ziekenhuisgroep is a leading healthcare institution in the Netherlands, dedicated to providing high-quality patient care and advancing medical research through innovative clinical trials. With a commitment to improving health outcomes, the organization fosters collaboration among multidisciplinary teams to explore new treatment options and enhance existing therapies. Noordwest Ziekenhuisgroep emphasizes ethical standards and patient safety in all its research endeavors, ensuring that clinical trials are conducted with the utmost rigor and adherence to regulatory guidelines. Through its research initiatives, the institution aims to contribute significantly to the medical community and improve the lives of patients both locally and globally.

Locations

Alkmaar, , Netherlands

Patients applied

0 patients applied

Trial Officials

METC AUMC

Study Chair

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported