An interventional study of CBCL and SDQ in Preterm Birth, Developmental Delay and Growth Delay, sponsored by Noordwest Ziekenhuisgroep. Completed at 1 site in Netherlands. Open to participants aged 9 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Noordwest Ziekenhuisgroep · Not applicable, Interventional, and Basic science
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.
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 or 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 or 9 year old children of employees of Noordwest Hospital and all born at full term.
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 or 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 and 9 year old children of employees of Noordwest Hospital and all born at full term 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 or 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 and 9 year old children of employees of Noordwest Hospital and all 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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2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 153 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Noordwest Ziekenhuisgroep is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, a subject must meet all the following criteria:
In order to be eligible to participate in the control group of this study, a subject must meet all the following criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
A potential subject who meets any of the following criteria will be excluded from participation in this study as part of the control group:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
A questionnaire on behaviour
Also known as: Child Behaviour Checklist
A questionnaire on behaviour
Also known as: Strength and Difficulties Questionnaire
A questionnaire on communcational skills
Also known as: Children's Communication Checklist
A questionnaire on feeding problems
Also known as: Montreal Children's Hospital Feeding Scale
A questionnaire on behaviour
Also known as: Teacher report form
An IQ test for children
Also known as: Wechsler Intelligence Scale of Development for Children
A test to assess motor function
Also known as: MABC-II-NL
A test to assess language development
Also known as: Clinical Evaluation of Language Fundamentals
Test of executive functions
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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At 9 years of age
Behavioural and psychosocial outcomes of the CBCL
Each item is scored using the scale: 0 = not true (as far as you know); 1 = somewhat or sometimes true; 2 = very true or often true. A total score of total behavorial problems is calculated and divided ingeTotal Score of behaviorial problems divided in internlizing behavorial problems and external behaviorial problems. A total T- score above 50 indicates that there are more problems than de controlgroup. the higher the score the more problems.
Time frame: At 9 years of age
Speech- and language-developmental scores on CELF-5-NL
Standard Score: This scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3. A scaled score of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively The Children's Communication Checklist-2 U.S. Edition is a parent or caregiver rating scale based on the extensive research of author, Dr. Dorothy Bishop. CCC-2 helps rate aspects of communication, screens for general language, and identifies pragmatic language impairment. Domains that are tested is language: speech, syntax, sematics and coherence and pragmatics in scores. These scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3 of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively
Time frame: At 9 years of age
Children's Communication List CCC-2-NL
The Children's Communication Checklist-2 U.S. Edition is a parent or caregiver rating scale based on the extensive research of author, Dr. Dorothy Bishop. CCC-2 helps rate aspects of communication, screens for general language, and identifies pragmatic language impairment. Domains that are tested is language: speech, syntax, sematics and coherence and pragmatics in scores. These scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3 of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively
Time frame: At 9 years of age
The Strengths and Difficulties Questionnaire (SDQ)
The SDQ is a brief behavioural screening questionnaire about 2-17 year olds. It includes between one and three of the following components: A) 25 items on psychological attributes. All versions of the SDQ ask about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales: 1. emotional symptoms (5 items) 2. conduct problems (5 items) 3. hyperactivity/inattention (5 items) 4. peer relationship problems (5 items) 5. prosocial behaviour (5 items) A total score kan be calculated. A the T-score \< 80 is considered as normal, 80-90 might indicate small problems,, a score \> 90 indicates serious problems.
Time frame: At age of 9 years
Teacher Report Form (TRH)
This is the CBCL test filled in by the teacher. Each item is scored using the scale: 0 = not true (as far as you know); 1 = somewhat or sometimes true; 2 = very true or often true. A total score of total behavorial problems is calculated and divided ingeTotal Score of behaviorial problems divided in internlizing behavorial problems and external behaviorial problems. A total T- score above 50 indicates that there are more problems than de controlgroup. the higher the score the more problems.
Time frame: At 9 years of age
Montreal Childrens Hospital Feeding Scale (MCH)
The Montreal Children's Hospital Feeding Scale \[MCH-Feeding Scale\]) designed to identify feeding problems in children. Normal range = raw score 0-45 \[T-score 35-60\], mild difficulties = 46-52 \[T-score 61-65\], moderate 53-58 \[T-score 66-70\], severe \>=59 \[T-score \>70\].
Time frame: At 9 years of age
Plan to share: No
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Ran from Aug 2023 to primary completion in Jul 2026, 34 months.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 34 months is above that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Noordwest Ziekenhuisgroep