Clinical trial NCT05990582: The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years
Official title: Neurodevelopmental Outcomes and Morbidities of Moderate and Late Preterm Children at the Age of 9 Years -The Alkmaar MLPTI Cohort Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Preterm Birth
Developmental Delay
Growth Delay
Keywords: Moderate and late preterm infants
Neurodevelopmental outcomes
Growth
Morbidities
Lead sponsor: Noordwest Ziekenhuisgroep
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 140
Sex: ALL
Minimum age (years): 9
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Outcomes of a group of preterm born children are compared to a group of children born at term.
Primary purpose: BASIC_SCIENCE

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 (n=50).

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.

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 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 of debate and more research to this subject is warranted.

In addition, one recent study correlated impaired behavioural outcomes and lower IQ-scores at the age of 6 with the attentional and language scores of a Bayley Scales of Infant and Toddler Development (BSID-III) performed at the age of 1.5 to 2 years. This relation, however, is not confirmed in other studies. More research is therefore necessary to clarify the predictive value of these screening methods in early detection of impaired outcomes during school age, and to examine whether a longer follow-up could thereby help to prevent these problems.

Objective: To assess neurodevelopmental outcomes (including neurocognitive, motor, language, behavioral, and academic functioning), growth and morbidities in MLPTI children at the age of 9 born in the NWZ Alkmaar, and compare these outcomes to those of a sex and age-matched control group of friends of MLPTI children born at uncomplicated full term gestational age.

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. That study described growth, body composition and neurodevelopmental outcome 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. A total number of hundred children participated in the aforementioned study on growth and neurodevelopment at the age of 2 years. The oldest children of this cohort will reach the age of 9 years in January 2023. Sex and age-matched friends of these children whom are also 9 years old will be examined as control group of same aged peers (n=70).

Intervention: Parents will be asked to fill in five widely used questionnaires, including the Child Behaviour Checklist (CBCL), Strengths and Difficulties Questionnaire (SDQ), Childrens Communication Checklist (CCC-2-NL), Montreal Childrens Hospital Feeding Scale (MCH Feeding Scale) and a custom made questionnaire on morbidities. Teachers will be asked to complete the Teacher report form (TRF)), which is a version of the CBCL adapted for teachers. Children will visit the outpatient clinic once for neurodevelopmental assessment, including the Wechsler Intelligence Scale of Development for Children (WISC-V-NL) to assess intelligence (IQ), the EMMA-Toolbox to assess neurocognitive functioning, the Movement ABC (MABC-II-NL) to assess motor function, and subtests of the Clinical Evaluation of Language Fundamentals (CELF-5-NL) to assess language development. Furthermore, academic achievement will be assessed using existing data collected at school as part of the student monitoring system (National Institute for Educational Measurement (CITO)). During the same single visit, length, weight, waist circumference and blood pressure will be measured to analyse the body composition.

Main study parameters/endpoints: To examine neurodevelopmental outcomes (including neurocognitive, motor, language, and (eating-)behavioral function, and academic achievement), growth and morbidities in MLPTI children at the age of 9 born in the Noordwest Ziekenhuis, location Alkmaar, and compare them with a control group of 9 year old friends born at full term.

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, The Montreal Children Hospital feeding Scale and Teacher Report Form 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.

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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

Primary outcomes:
measure: Full scale IQ
timeFrame: At 9 years of age
measure: M-ABC score
timeFrame: At 9 years of age
measure: Executive functions on Emma-Toolbox
timeFrame: At 9 years of age
measure: Prevalence of Morbidities
timeFrame: At 9 years of age
measure: Measurements of growth
timeFrame: At 9 years of age
measure: Blood Pressure at 9 years of age
timeFrame: At 9 years of age
Secondary outcomes:
measure: Behavioural and psychosocial outcomes of the CBCL
timeFrame: At 9 years of age
measure: Speech- and language-developmental scores on CELF-5-NL
timeFrame: At 9 years of age
measure: Children's Communication List CCC-2-NL
timeFrame: At 9 years of age
measure: The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: At age of 9 years
measure: Teacher Report Form (TRH)
timeFrame: At 9 years of age
measure: Montreal Childrens Hospital Feeding Scale (MCH)
timeFrame: At 9 years of age
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: METC AUMC
role: STUDY_CHAIR
References: