The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years
- Conditions
- Developmental DelayGrowth DelayPreterm Birth
- Interventions
- Diagnostic Test: CBCLDiagnostic Test: SDQDiagnostic Test: CCC-2-NLDiagnostic Test: MCH Feeding scaleDiagnostic Test: TRFDiagnostic Test: WISC-5-NLDiagnostic Test: Movement ABCDiagnostic Test: CELF-5-NLDiagnostic Test: Emma Toolbox
- Registration Number
- NCT05990582
- Lead Sponsor
- Noordwest Ziekenhuisgroep
- 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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Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 140
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control cohort CBCL Group of 9 year old children born at term MLPTI Cohort WISC-5-NL Group of 9 year old children born between 32 and 36 weeks of gestational age MLPTI Cohort CELF-5-NL Group of 9 year old children born between 32 and 36 weeks of gestational age MLPTI Cohort SDQ Group of 9 year old children born between 32 and 36 weeks of gestational age Control cohort SDQ Group of 9 year old children born at term MLPTI Cohort CCC-2-NL Group of 9 year old children born between 32 and 36 weeks of gestational age MLPTI Cohort Movement ABC Group of 9 year old children born between 32 and 36 weeks of gestational age Control cohort CCC-2-NL Group of 9 year old children born at term MLPTI Cohort MCH Feeding scale Group of 9 year old children born between 32 and 36 weeks of gestational age MLPTI Cohort Emma Toolbox Group of 9 year old children born between 32 and 36 weeks of gestational age Control cohort Emma Toolbox Group of 9 year old children born at term MLPTI Cohort CBCL Group of 9 year old children born between 32 and 36 weeks of gestational age MLPTI Cohort TRF Group of 9 year old children born between 32 and 36 weeks of gestational age Control cohort WISC-5-NL Group of 9 year old children born at term Control cohort Movement ABC Group of 9 year old children born at term Control cohort CELF-5-NL Group of 9 year old children born at term Control cohort MCH Feeding scale Group of 9 year old children born at term Control cohort TRF Group of 9 year old children born at term
- Primary Outcome Measures
Name Time Method Full scale IQ At 9 years of age 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 averageM-ABC score At 9 years of age 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)
Measurements of growth At 9 years of age Length, weight, head and abdominal circumference are measured in cm. Parental height will be measured in cm.
Executive functions on Emma-Toolbox At 9 years of age 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.
Prevalence of Morbidities At 9 years of age 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
Blood Pressure at 9 years of age At 9 years of age Systolic bloodpressure in mmHg, range 5-200 Diastolic blood pressure in mmHg p-value is conducted for age.
- Secondary Outcome Measures
Name Time Method Behavioural and psychosocial outcomes of the CBCL At 9 years of age 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.
Children's Communication List CCC-2-NL At 9 years of age 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, respectivelyMontreal Childrens Hospital Feeding Scale (MCH) At 9 years of age 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 \[T-score \>70\].Speech- and language-developmental scores on CELF-5-NL At 9 years of age 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, respectivelyThe Strengths and Difficulties Questionnaire (SDQ) At age of 9 years 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.Teacher Report Form (TRH) At 9 years of age 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.
Trial Locations
- Locations (1)
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands