Preterm InfantNCT03700619
Executive Functions and Preterm Children in 11 to 12 Year Old
An observational study of Preterm Infant, run by Nantes University Hospital at 1 site in France.
Trial summary
Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidence of executive functions is not described for preterm infants. Read more about this study
- Who is it for?
- Ages 11 to 12 years
- Conditions the study is for
- Preterm Infant
- What is being tested?
- BRIEF parental survey
- How many people
- 355 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2019to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 11 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: patients which former preterm of gestational age less than 34 weeks
Who may be able to join
- patient in 11 to 12 year old, included in LIFT cohort
Who cannot join
- Congenital abnormalities including nervous system malformations; genetic diseases; incomplete understanding of written and oral French by parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Executive Functions in Preterm Children in 11 to 12 Year Old From the Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire
Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidence of executive functions is not described for preterm infants.
Read the detailed description
It is an epidemiologic, observational, prospective study. All patients, included in the LIFT cohort, in 11 to 12 year old during the period study, are contacted by mail. Patients with congenital anomalies or genetic syndromes are excluded. Children with parents who do not speak French are excluded. Antenatal and postnatal criteria known to be associated with disorders of executive functions are collected as gestational age, sex, multiple pregnancy, intrauterine growth retardation, antenatal or postnatal steroid use, breastfeeding, cerebral injuries and socio-economic status. After a couple of weeks, parents are contacted by a study manager, by phone call, to collect parental consent and answer some parental questions. After consent collect, BRIEF questionnaires are sending. If they wish, parents could give the BRIEF teacher questionnaire to the mean teacher. Teachers send by themselves their response. An informatic version is available with a personal link given especially by mail for each child. All data are anonymous. BRIEF questionnaire is composed of 86 items, exploring 2 main domains: behavior and metacognition. Twenty minutes are necessary to complete questionnaire. In case of no questionnaire return after one month, parents are contacted by phone. The investigators hypothesize a lost to follow-up at 0.25 and no response at 0.35. The response expected is 300 questionnaires.
- Conditions
- Preterm Infant
- Being tested
- BRIEF parental survey
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIEF parental surveyOther
estimate incidence of executive functions disorders in preterm children in 11 to 12 year old, born less than 34 weeks of gestation, with the BRIEF parental questionnaire. Effects are potentially important because this study could objectify an increase of risk of executive functions disorders f in preterm children in 11 to 12 year old, and identify associated risk factors. This work could eventually alert pediatrician to be careful at the executive functions and to propose adapted supportive cares.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of disorders of executive functions in 11 to 12 year old in former preterm of gestational age less than 34 weeks, from the Behavioral Rating Inventory of Executive Function questionnaire.
The sum of the 86 items is calculated.
Measured: 11 to 12 years after preterm birth.
Secondary outcomes (1)
Find neonatal factors associated with executive functions disorders in former prematures in 11 to 12 year old
estimate adequacy between BRIEF questionnaire performed/completed by parents and BRIEF questionnaire performed by teacher.
Measured: 11 to 12 years after preterm birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start30 Jan 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700619
- Sponsor's protocol ID
- RC18_0201
- Status last verified
- Sep 2021
- First submitted
- 5 Oct 2018
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Executive Functions in Preterm Children in 11 to 12 Year Old From the Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire
- ClinicalTrials.gov ID
- NCT03700619
- Acronym / sponsor ID
- RC18_0201
- Conditions
- Preterm Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 Oct 2018 (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.
Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidence of executive functions is not described for preterm infants.
Detailed description
It is an epidemiologic, observational, prospective study. All patients, included in the LIFT cohort, in 11 to 12 year old during the period study, are contacted by mail. Patients with congenital anomalies or genetic syndromes are excluded. Children with parents who do not speak French are excluded. Antenatal and postnatal criteria known to be associated with disorders of executive functions are collected as gestational age, sex, multiple pregnancy, intrauterine growth retardation, antenatal or postnatal steroid use, breastfeeding, cerebral injuries and socio-economic status. After a couple of weeks, parents are contacted by a study manager, by phone call, to collect parental consent and answer some parental questions. After consent collect, BRIEF questionnaires are sending. If they wish, parents could give the BRIEF teacher questionnaire to the mean teacher. Teachers send by themselves their response. An informatic version is available with a personal link given especially by mail for each child. All data are anonymous. BRIEF questionnaire is composed of 86 items, exploring 2 main domains: behavior and metacognition. Twenty minutes are necessary to complete questionnaire. In case of no questionnaire return after one month, parents are contacted by phone. The investigators hypothesize a lost to follow-up at 0.25 and no response at 0.35. The response expected is 300 questionnaires.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients which former preterm of gestational age less than 34 weeks
Key inclusion criteria (1 listed)
- patient in 11 to 12 year old, included in LIFT cohort
Key exclusion criteria (1 listed)
- Congenital abnormalities including nervous system malformations; genetic diseases; incomplete understanding of written and oral French by parents
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 |
|---|---|---|
| BRIEF parental surveyestimate incidence of executive functions disorders in preterm children in 11 to 12 year old, born less than 34 weeks of gestation, with the BRIEF parental questionnaire. Effects are potentially important because this study could objectify an increase of risk of executive functions disorders f in preterm children in 11 to 12 year old, and identify associated risk factors. This work could eventually alert pediatrician to be careful at the executive functions and to propose adapted supportive cares. | Other | – |
Primary outcome
Incidence of disorders of executive functions in 11 to 12 year old in former preterm of gestational age less than 34 weeks, from the Behavioral Rating Inventory of Executive Function questionnaire.
Time frame: 11 to 12 years after preterm birth.
The sum of the 86 items is calculated.
1 secondary outcome
Find neonatal factors associated with executive functions disorders in former prematures in 11 to 12 year old
Time frame: 11 to 12 years after preterm birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
Related trials for Preterm Infant
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant, run by Nantes University Hospital at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of disorders of executive functions in 11 to 12 year old in former preterm of gestational age less than 34 weeks, from the Behavioral Rating Inventory of Executive Function questionnaire. (time frame: 11 to 12 years after preterm birth.). 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 10 Sep 2021.