The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years

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

Interventions

DIAGNOSTIC_TEST

CBCL

A questionnaire on behaviour

DIAGNOSTIC_TEST

SDQ

A questionnaire on behaviour

DIAGNOSTIC_TEST

CCC-2-NL

A questionnaire on communcational skills

DIAGNOSTIC_TEST

MCH Feeding scale

A questionnaire on feeding problems

DIAGNOSTIC_TEST

TRF

A questionnaire on behaviour

DIAGNOSTIC_TEST

WISC-5-NL

An IQ test for children

DIAGNOSTIC_TEST

Movement ABC

A test to assess motor function

DIAGNOSTIC_TEST

CELF-5-NL

A test to assess language development

DIAGNOSTIC_TEST

Emma Toolbox

Test of executive functions

Sponsors & Collaborators

• Noordwest Ziekenhuisgroep

  lead OTHER

Principal Investigators

• METC AUMC · Amsterdam UMC

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

9 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-11

Primary Completion

2026-04-17

Completion

2026-05-28

Countries

• Netherlands

Study Locations