Intrauterine Growth RestrictionLOOPNCT06534307
Long-term Follow-up of Children Born in the PETN Studies
An observational study of Intrauterine Growth Restriction and Pentaerithrityl Teratnitrate in Pregnancy, run by Jena University Hospital at 13 sites in Germany.
Trial summary
In every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. This occurs when the child cannot reach its growth potential due to an undersupply in the uterus. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Intrauterine Growth Restriction, Pentaerithrityl Teratnitrate in Pregnancy, Long-Term Effects to Children
- What is being tested?
- Questionnaire Child Behaviour Checklist, Questionnaire Young Self Report and physical examination
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 228 participants
- Where
- 13 sitesGermany
- Study dates
- 1 Jun 2024to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all live born children from participants of the PETN-studies
Who may be able to join
- mothers participation in one of the PETN studies
- age above 5 years
- completion of questionnaires for self reported data
- written consent for physical examination
Who cannot join
- physical and mental states preventing physical examination
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Germany13 sites, 13 recruiting
- Not yet recruiting
Berlin Charité Campus Mitte
Berlin, 10117
Stefan Verlohren, PD Dr.
- Not yet recruiting
Berlin Vivantes Klinikum Neukölln
Berlin, 12351
Wolfgang Schlembach, PD Dr.
- Not yet recruiting
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Mateja Condic
Julia Welz
- Not yet recruiting
Universitätsklinikum Dresden
Dresden, Saxony, 01307
Matej Komar, Dr.
Jennifer L Winkler, Dr.
- Not yet recruiting
Krankenhaus St. Elisabeth und St. Barbara
Halle, Saxony-Anhalt, 06110
Sven Seeger, Dr.
Yvonne Jäger, Dr.
- Not yet recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Constantin von Kaisenberg, Pr. Dr.
Matthias Jentschke, Dr.
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07747
Tanja Groten, Prof. Dr., 0361 9 32 92 01, Loop@med.uni-jena.de
Ekkehard Schleußner, Prof. Dr.
- Not yet recruiting
Universitätsklinikum Schleswig Holstein
Kiel, Schleswig-Holstein, 24105
Ulrich Pecks, PD Dr.
Christel Eckmann, Prof. Dr.
- Not yet recruiting
Uniklinikum Leipzig
Leipzig, Saxony, 04103
Anne Tauscher, Dr.
Susanne Schrey-Petersen, Dr.
- Not yet recruiting
Klinikum der Universität München
München, Bavaria, 81377
Christoph Hübener, Dr.
- Not yet recruiting
Städtisches Klinikum München
München, Bavaria, 81545
Laura de Vries, Dr.
Ninette Scharle
- Not yet recruiting
Universitäts-Frauenklinik Tübingen
Tübingen, Baden-Wurttemberg, 72076
Karl O Kagan, Dr.
Harald Abele, Prof. Dr.
- Not yet recruiting
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89075
Ulrike Friebe-Hoffmann, PD Dr.
About this study
Official title: Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
In every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. This occurs when the child cannot reach its growth potential due to an undersupply in the uterus. This inadequate supply is considered a developmental cause for the later development of physical diseases like cardiovascular diseases, sugar metabolism disorders and obesity as well as mental developmental problems (for example problems in cognitive skills, deficits in language development, concentration and attention).
From 2002 to 2008, 111 patients with impaired placental blood flow were included in a small study and treated with Pentalong or placebo. From 2017 to 2022, the positive effects of the study treatment were tested on a larger number of patients. A total of 317 pregnant women were included at 14 participating study centers in Germany.
In this follow-up study, the development of the children born in the two studies will be examined. The study consists of two independent parts: firstly, questionnaires are answered by the former participants and secondly, an on-site visit is carried out to check the physical and mental health of the child.
Read the detailed description
Pregnancies in which impaired uterine blood flow is detected by Doppler measurements during routine examinations in the second trimester are at high risk of developing fetal growth restriction (FGR). FGR affects 10% of pregnancies and is the leading cause of perinatal mortality and morbidity. In addition, intrauterine growth restriction places a lifelong burden on the physical and mental health of affected children. Epidemiological studies have shown that children with FGR have an increased risk of developing type 2 diabetes mellitus, hypertension, dyslipidemia and a high BMI. In addition, the affected children show disorders in hormonal balance and pubertal development as well as specific impairments of various cognitive and neurocognitive functions. There is also a link between FGR and lower cognitive ability in preschool children, school-age children and young adults, as well as lower communication, language and reading skills in school-age children. Neuronal development (e.g. EEG frequency spectra, resting-state networks) and executive functions are also impaired by FGR.
In the follow-up study, the children will be examined from the age of 6. Here, the effects of PETN on the development of children of women with high-risk pregnancies can be further investigated and a comparative study of growth-retarded and normal-growth children can also be carried out.
- Conditions
- Intrauterine Growth Restriction, Pentaerithrityl Teratnitrate in Pregnancy, Long-Term Effects to Children
- Being tested
- Questionnaire Child Behaviour Checklist, Questionnaire Young Self Report, physical examination, metabolic examination, Questionnaire Reynolds Intellectual Assessment Scales and Screening
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire Child Behaviour ChecklistBehavioural
Also called CBCL/6-18R
The Child Behavior Checklist comprises items assigned to 8 subscales describing various behavioral areas. These subscales can be summed up to scores for internalizing and externalizing problems as well as a total score. Checklist scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean higher amount of problems.
Questionnaire Young Self ReportBehavioural
Also called YSR/11-18R
The Questionnaire Young Self Report comprises items assigned to 8 subscales describing various behavioral areas. These subscales can be summed up to scores for internalizing and externalizing problems as well as a total score.
physical examinationDiagnostic test
physical development examination including height (in cm), weight (in g) and tanner states
metabolic examinationDiagnostic test
metabolic development using blood analysis including blood components, metabolic parameters (Glucose, HbA1c, cholestrol)
Questionnaire Reynolds Intellectual Assessment Scales and ScreeningBehavioural
Also called RIAS
The RIAS is standardized intelligence test. The RIAS provides an "Total Intelligence Index" (GIX, estimate of the general intelligence/g-factor), Verbal Intelligence Index (VIX) and the Nonverbal Intelligence Index (NIX). Test scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean better cognitive performance.
electroencephalogramDiagnostic test
Also called EEG
neurocognitive development
Questionnaire Movement Assessment Battery for ChildrenOther
Also called M-ABC-2
The M-ABC-2 is an standardized test to assess the motoric development. Adding up subscores addressing manual dexterity, aiming and catching, and balance delivers a total score of the motoric performance.
Test scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean better performance.
Questionnaire Continuous Performance TestOther
Also called CPT
The CPT measures selective attention, sustained attention as well as impulsive behavior. Checklist scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean worse performance.
Questionnaire Diagnostic System for Mental DisordersOther
Also called FBB-ADHS
The FBB-ADHS assesses a total score for ADHD-like behavior and subscores for the symptom trias of ADHD (attention deficit, motoric hyperactivity as well as impulsive behavior, Questionnaire scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean higher amount of symptoms.
kidney function testsDiagnostic test
urine examination (proteomics, cytokines, lipidomics)
Questionnaire Five to FifteenOther
Also called FTF 5-15R
The FTF 5-15R is a questionnaire to evaluate the child's developmental outcome in different areas of everyday life (cognition, language, and motor impairment as well as social, emotional, and behavioral problems). Individual item scores are added up per area and divided by the number of items. This results in a common scale value. Range of Percentile scores from 0 to 100 (0-90: no developmental problem; 90 and higher: hint for developmental problem). Higher scores mean worse developmental outcome.
cardiovacular examinationDiagnostic test
Also called Arteriograph
measurement of pulse wave velocity
| Study group | Role | What they receive |
|---|---|---|
| Placebo | children of mothers that have been taken placebos during participation of PETN study Receives: Behavioral: Questionnaire Child Behaviour Checklist; Behavioral: Questionnaire Young Self Report; Diagnostic Test: physical examination; Diagnostic Test: metabolic examination; Behavioral: Questionnaire Reynolds Intellectual Assessment Scales and Screening; Diagnostic Test: electroencephalogram; Other: Questionnaire Movement Assessment Battery for Children; Other: Questionnaire Continuous Performance Test; Other: Questionnaire Diagnostic System for Mental Disorders; Diagnostic Test: kidney function tests; Other: Questionnaire Five to Fifteen; Diagnostic Test: cardiovacular examination | |
| PETN | children of mothers that have been taken in PETN during participation of PETN study Receives: Behavioral: Questionnaire Child Behaviour Checklist; Behavioral: Questionnaire Young Self Report; Diagnostic Test: physical examination; Diagnostic Test: metabolic examination; Behavioral: Questionnaire Reynolds Intellectual Assessment Scales and Screening; Diagnostic Test: electroencephalogram; Other: Questionnaire Movement Assessment Battery for Children; Other: Questionnaire Continuous Performance Test; Other: Questionnaire Diagnostic System for Mental Disorders; Diagnostic Test: kidney function tests; Other: Questionnaire Five to Fifteen; Diagnostic Test: cardiovacular examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
childrens behaviour
total score of either CBCL/16-18R or YSR/11-18R
Measured: up to 2 years after study inclusion
Secondary outcomes (16)
physical development height
height of the child in cm
Measured: up to 2 years after study inclusion
physical development weight
weight of the child in kg
Measured: up to 2 years after study inclusion
age appropriate development
age appropriate development documented as "yes or no" question in german routine examination plan ("Kinderuntersuchungsheft") in the last 6 years at caregivers
Measured: up to 2 years after study inclusion
cognitive, motoric, and exectuve function
scores of the eight domains of the FTF 5-15-R
Measured: up to 2 years after study inclusion
physical development
self reported tanner states
Measured: age above 10 years
cardiovascular development
pulse wave velosity
Measured: age of 6 to 8 years
IQ development
scores of RIAS test
Measured: age of 6 to 8 years
motoric development
total score of M-ABC-2
Measured: age of 6 to 8 years
attention behaviour
scores of the four domains of the cpt
Measured: age of 6 to 8 years
symptoms of attention and activity disorders
total scores of DISYPS-III
Measured: age of 6 to 8 years
neurocognitive development
results of EEG power measurement in alpha band
Measured: age of 6 to 8 years
neurocognitive development
results of EEG power measurement in beta band
Measured: age of 6 to 8 years
neurocognitive development
results of EEG power measurement in gamma band
Measured: age of 6 to 8 years
neurocognitive development
results of EEG power measurement in delta band
Measured: age of 6 to 8 years
neurocognitive development
results of EEG power measurement in theta band
Measured: age of 6 to 8 years
epigenetic analysis
DNA-methylation
Measured: age of 6 to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jun 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanja Groten, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534307
- Sponsor's protocol ID
- ZKSJ0133
- Acronym
- LOOP
- Status last verified
- Aug 2024
- First submitted
- 14 May 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
- ClinicalTrials.gov ID
- NCT06534307
- Acronym / sponsor ID
- LOOP / ZKSJ0133
- Conditions
- Intrauterine Growth Restriction, Pentaerithrityl Teratnitrate in Pregnancy, Long-Term Effects to Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. This occurs when the child cannot reach its growth potential due to an undersupply in the uterus. This inadequate supply is considered a developmental cause for the later development of physical diseases like cardiovascular diseases, sugar metabolism disorders and obesity as well as mental developmental problems (for example problems in cognitive skills, deficits in language development, concentration and attention).
From 2002 to 2008, 111 patients with impaired placental blood flow were included in a small study and treated with Pentalong or placebo. From 2017 to 2022, the positive effects of the study treatment were tested on a larger number of patients. A total of 317 pregnant women were included at 14 participating study centers in Germany.
In this follow-up study, the development of the children born in the two studies will be examined. The study consists of two independent parts: firstly, questionnaires are answered by the former participants and secondly, an on-site visit is carried out to check the physical and mental health of the child.
Detailed description
Pregnancies in which impaired uterine blood flow is detected by Doppler measurements during routine examinations in the second trimester are at high risk of developing fetal growth restriction (FGR). FGR affects 10% of pregnancies and is the leading cause of perinatal mortality and morbidity. In addition, intrauterine growth restriction places a lifelong burden on the physical and mental health of affected children. Epidemiological studies have shown that children with FGR have an increased risk of developing type 2 diabetes mellitus, hypertension, dyslipidemia and a high BMI. In addition, the affected children show disorders in hormonal balance and pubertal development as well as specific impairments of various cognitive and neurocognitive functions. There is also a link between FGR and lower cognitive ability in preschool children, school-age children and young adults, as well as lower communication, language and reading skills in school-age children. Neuronal development (e.g. EEG frequency spectra, resting-state networks) and executive functions are also impaired by FGR.
In the follow-up study, the children will be examined from the age of 6. Here, the effects of PETN on the development of children of women with high-risk pregnancies can be further investigated and a comparative study of growth-retarded and normal-growth children can also be carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | Behavioral: Questionnaire Child Behaviour Checklist, Behavioral: Questionnaire Young Self Report, Diagnostic Test: physical examination, Diagnostic Test: metabolic examination, Behavioral: Questionnaire Reynolds Intellectual Assessment Scales and Screening, Diagnostic Test: electroencephalogram, Other: Questionnaire Movement Assessment Battery for Children, Other: Questionnaire Continuous Performance Test, Other: Questionnaire Diagnostic System for Mental Disorders, Diagnostic Test: kidney function tests, Other: Questionnaire Five to Fifteen, Diagnostic Test: cardiovacular examinationchildren of mothers that have been taken placebos during participation of PETN study |
| PETN | – | Behavioral: Questionnaire Child Behaviour Checklist, Behavioral: Questionnaire Young Self Report, Diagnostic Test: physical examination, Diagnostic Test: metabolic examination, Behavioral: Questionnaire Reynolds Intellectual Assessment Scales and Screening, Diagnostic Test: electroencephalogram, Other: Questionnaire Movement Assessment Battery for Children, Other: Questionnaire Continuous Performance Test, Other: Questionnaire Diagnostic System for Mental Disorders, Diagnostic Test: kidney function tests, Other: Questionnaire Five to Fifteen, Diagnostic Test: cardiovacular examinationchildren of mothers that have been taken in PETN during participation of PETN study |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all live born children from participants of the PETN-studies
Key inclusion criteria (4 listed)
- mothers participation in one of the PETN studies
- age above 5 years
- completion of questionnaires for self reported data
- written consent for physical examination
Key exclusion criteria (1 listed)
- physical and mental states preventing physical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire Child Behaviour ChecklistAlso: CBCL/6-18RThe Child Behavior Checklist comprises items assigned to 8 subscales describing various behavioral areas. These subscales can be summed up to scores for internalizing and externalizing problems as well as a total score. Checklist scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean higher amount of problems. | Behavioural | PETN, Placebo |
| Questionnaire Young Self ReportAlso: YSR/11-18RThe Questionnaire Young Self Report comprises items assigned to 8 subscales describing various behavioral areas. These subscales can be summed up to scores for internalizing and externalizing problems as well as a total score. | Behavioural | PETN, Placebo |
| physical examinationphysical development examination including height (in cm), weight (in g) and tanner states | Diagnostic test | PETN, Placebo |
| metabolic examinationmetabolic development using blood analysis including blood components, metabolic parameters (Glucose, HbA1c, cholestrol) | Diagnostic test | PETN, Placebo |
| Questionnaire Reynolds Intellectual Assessment Scales and ScreeningAlso: RIASThe RIAS is standardized intelligence test. The RIAS provides an "Total Intelligence Index" (GIX, estimate of the general intelligence/g-factor), Verbal Intelligence Index (VIX) and the Nonverbal Intelligence Index (NIX). Test scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean better cognitive performance. | Behavioural | PETN, Placebo |
| electroencephalogramAlso: EEGneurocognitive development | Diagnostic test | PETN, Placebo |
| Questionnaire Movement Assessment Battery for ChildrenAlso: M-ABC-2The M-ABC-2 is an standardized test to assess the motoric development. Adding up subscores addressing manual dexterity, aiming and catching, and balance delivers a total score of the motoric performance. Test scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean better performance. | Other | PETN, Placebo |
| Questionnaire Continuous Performance TestAlso: CPTThe CPT measures selective attention, sustained attention as well as impulsive behavior. Checklist scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean worse performance. | Other | PETN, Placebo |
| Questionnaire Diagnostic System for Mental DisordersAlso: FBB-ADHSThe FBB-ADHS assesses a total score for ADHD-like behavior and subscores for the symptom trias of ADHD (attention deficit, motoric hyperactivity as well as impulsive behavior, Questionnaire scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean higher amount of symptoms. | Other | PETN, Placebo |
| kidney function testsurine examination (proteomics, cytokines, lipidomics) | Diagnostic test | PETN, Placebo |
| Questionnaire Five to FifteenAlso: FTF 5-15RThe FTF 5-15R is a questionnaire to evaluate the child's developmental outcome in different areas of everyday life (cognition, language, and motor impairment as well as social, emotional, and behavioral problems). Individual item scores are added up per area and divided by the number of items. This results in a common scale value. Range of Percentile scores from 0 to 100 (0-90: no developmental problem; 90 and higher: hint for developmental problem). Higher scores mean worse developmental outcome. | Other | PETN, Placebo |
| cardiovacular examinationAlso: Arteriographmeasurement of pulse wave velocity | Diagnostic test | PETN, Placebo |
Primary outcome
childrens behaviour
Time frame: up to 2 years after study inclusion
total score of either CBCL/16-18R or YSR/11-18R
16 secondary outcomes
physical development height
Time frame: up to 2 years after study inclusion
physical development weight
Time frame: up to 2 years after study inclusion
age appropriate development
Time frame: up to 2 years after study inclusion
cognitive, motoric, and exectuve function
Time frame: up to 2 years after study inclusion
physical development
Time frame: age above 10 years
cardiovascular development
Time frame: age of 6 to 8 years
IQ development
Time frame: age of 6 to 8 years
motoric development
Time frame: age of 6 to 8 years
attention behaviour
Time frame: age of 6 to 8 years
symptoms of attention and activity disorders
Time frame: age of 6 to 8 years
neurocognitive development
Time frame: age of 6 to 8 years
neurocognitive development
Time frame: age of 6 to 8 years
neurocognitive development
Time frame: age of 6 to 8 years
neurocognitive development
Time frame: age of 6 to 8 years
neurocognitive development
Time frame: age of 6 to 8 years
epigenetic analysis
Time frame: age of 6 to 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction and Pentaerithrityl Teratnitrate in Pregnancy, run by Jena University Hospital at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
childrens behaviour (time frame: up to 2 years after study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.