The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years

NCT05990582 | Active Not Recruiting DMC

• 1 other identifier: NL82197.029.22
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Preterm Birth; Developmental Delay; Growth Delay

Keywords

Moderate and late preterm infants; Neurodevelopmental outcomes; Growth; Morbidities

Outcome Measures

Primary Outcomes (6)

• Full scale IQ

  The primary index scores and the FSIQ are on a standard score metric with a mean of 100 and an SD of 15. The primary index scores range from 45 to 155; the FSIQ ranges from 40 to 160. For both the primary index scores and the FSIQ, scores ranging from 90 to 109 are typically considered average

  At 9 years of age

• M-ABC score

  Standard Score: Total and percentile Total score 0, percentile 96-100 (high) Totalscore 4, percentile 54 (moderate) Totalscore 10, percentile 15 (consider help/intervention) totalscore 13,5, percentile 5 (intervention needed)

  At 9 years of age

• Executive functions on Emma-Toolbox

  Processing speed \& Control Verbal Memory Visual memory Verbal working Memory Visual Working Memory Interpretation: Cortex. 2021 Oct;143:12-28. doi: 10.1016/j.cortex.2021.06.011. Epub 2021 Jul 14 Visuomotoric integration.

  At 9 years of age

• Prevalence of Morbidities

  This questionary scores the following morbities in percentages (numbers of participants with): re-admission in hospital, amount of infections, eczema, astma, speech and developmental problems, medication use, operations

  At 9 years of age

• Measurements of growth

  Length, weight, head and abdominal circumference are measured in cm. Parental height will be measured in cm.

  At 9 years of age

• Blood Pressure at 9 years of age

  Systolic bloodpressure in mmHg, range 5-200 Diastolic blood pressure in mmHg p-value is conducted for age.

  At 9 years of age

Secondary Outcomes (6)

• Behavioural and psychosocial outcomes of the CBCL

  At 9 years of age

• Speech- and language-developmental scores on CELF-5-NL

  At 9 years of age

• Children's Communication List CCC-2-NL

  At 9 years of age

• The Strengths and Difficulties Questionnaire (SDQ)

  At age of 9 years

• Teacher Report Form (TRH)

  At 9 years of age

Study Arms (2)

MLPTI Cohort

EXPERIMENTAL

Group of 9 year old children born between 32 and 36 weeks of gestational age

Diagnostic Test: CBCL; Diagnostic Test: SDQ; Diagnostic Test: CCC-2-NL; Diagnostic Test: MCH Feeding scale; Diagnostic Test: TRF; Diagnostic Test: WISC-5-NL; Diagnostic Test: Movement ABC; Diagnostic Test: CELF-5-NL; Diagnostic Test: Emma Toolbox

Control cohort

ACTIVE COMPARATOR

Group of 9 year old children born at term

Diagnostic Test: CBCL; Diagnostic Test: SDQ; Diagnostic Test: CCC-2-NL; Diagnostic Test: MCH Feeding scale; Diagnostic Test: TRF; Diagnostic Test: WISC-5-NL; Diagnostic Test: Movement ABC; Diagnostic Test: CELF-5-NL; Diagnostic Test: Emma Toolbox

Interventions

CBCL DIAGNOSTIC_TEST

A questionnaire on behaviour

Also known as: Child Behaviour Checklist

Control cohort; MLPTI Cohort

SDQ DIAGNOSTIC_TEST

A questionnaire on behaviour

Also known as: Strength and Difficulties Questionnaire

Control cohort; MLPTI Cohort

CCC-2-NL DIAGNOSTIC_TEST

A questionnaire on communcational skills

Also known as: Children's Communication Checklist

Control cohort; MLPTI Cohort

MCH Feeding scale DIAGNOSTIC_TEST

A questionnaire on feeding problems

Also known as: Montreal Children's Hospital Feeding Scale

Control cohort; MLPTI Cohort

TRF DIAGNOSTIC_TEST

A questionnaire on behaviour

Also known as: Teacher report form

Control cohort; MLPTI Cohort

WISC-5-NL DIAGNOSTIC_TEST

An IQ test for children

Also known as: Wechsler Intelligence Scale of Development for Children

Control cohort; MLPTI Cohort

Movement ABC DIAGNOSTIC_TEST

A test to assess motor function

Also known as: MABC-II-NL

Control cohort; MLPTI Cohort

CELF-5-NL DIAGNOSTIC_TEST

A test to assess language development

Also known as: Clinical Evaluation of Language Fundamentals

Control cohort; MLPTI Cohort

Emma Toolbox DIAGNOSTIC_TEST

Test of executive functions

Control cohort; MLPTI Cohort

Eligibility Criteria

• Age: 9 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Noordwest Ziekenhuisgroep: lead

Study Sites (1)

Noordwest Ziekenhuisgroep

Alkmaar, 1815JD, Netherlands

Location

MeSH Terms

Conditions

Premature Birth; Learning Disabilities; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• METC AUMC

  Amsterdam UMC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: Outcomes of a group of preterm born children are compared to a group of children born at term.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: August 11, 2023
• Primary Completion: April 17, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)