PretermNCT04073836
GMA and Peri in Moderate-late Preterms
An observational study of Preterm and Assessment, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants Read more about this study
- Who is it for?
- Ages 32 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Assessment, Risk Factor
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 31 Dec 2021
- How long will I take part?
- 18 Months
- 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 32 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects who were born between the week 32 + 0 days and the week 36 + 6 days
Who may be able to join
- Subjects who were born between the week 32 + 0 days and the week 36 + 6 days and who are admitted to the Hospital Nuestra Señora del Prado de Talavera de la Reina or the Hospital Virgen de la Salud de Toledo.
Who cannot join
- Any type of pre and perinatal diagnostic neurological involvement.
- Any type of pathology associated with prematurity.
- Children who have prescribed any of the following medications (10):
- Barbiturates
- Antiepileptic
- Indomethacin
- Dexamethasone
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Javier Merino Andrés
Toledo, 45006
Javier M Merino Andrés, MsC, +34 925 268 800 ext. 5822, Javier.Merino@uclm.es
About this study
Official title: Early Detection of the Cerebral Palsy in Moderate and Late Preterms Through the General Movements
To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants
Read the detailed description
Analyze a sample of moderate and late premature infants using general movements and verify which of them would have an early diagnosis of cerebral palsy and relate it to their risk factors for this pathology.
- Conditions
- Preterm, Assessment, Risk Factor, Cerebral Palsy
- Medical subject headings
- Premature Birth, Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
gestation weeks
Premature birth week
Measured: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
weight
measurement, World Health Organization percentile
Measured: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
size
measurement, World Health Organization percentile
Measured: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
cranial perimeter
measurement about head, World Health Organization percentile
Measured: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
Apgar
Outcome about Apgar Test
Measured: at birth of each preterm
Magnetic resonance imaging rating scale
Outcome about Neuroimaging in preterms
Measured: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
general movements outcome
Outcome about General Movements Assessment. Three outcomes about movement of preterm. Normal, Poor Repertoire and Cramped Synchronized
Measured: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
PERI outcome
Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- 150 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073836
- Sponsor's protocol ID
- jma001
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 29 Aug 2019
- 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 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of the Cerebral Palsy in Moderate and Late Preterms Through the General Movements
- ClinicalTrials.gov ID
- NCT04073836
- Acronym / sponsor ID
- jma001
- Conditions
- Preterm, Assessment, Risk Factor, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Aug 2019 (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.
To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants
Detailed description
Analyze a sample of moderate and late premature infants using general movements and verify which of them would have an early diagnosis of cerebral palsy and relate it to their risk factors for this pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects who were born between the week 32 + 0 days and the week 36 + 6 days
Key inclusion criteria (1 listed)
- Subjects who were born between the week 32 + 0 days and the week 36 + 6 days and who are admitted to the Hospital Nuestra Señora del Prado de Talavera de la Reina or the Hospital Virgen de la Salud de Toledo.
Key exclusion criteria (7 listed)
- Any type of pre and perinatal diagnostic neurological involvement.
- Any type of pathology associated with prematurity.
- Children who have prescribed any of the following medications (10):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gestation weeks
Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
Premature birth week
weight
Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
measurement, World Health Organization percentile
size
Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
measurement, World Health Organization percentile
cranial perimeter
Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
measurement about head, World Health Organization percentile
Apgar
Time frame: at birth of each preterm
Outcome about Apgar Test
Magnetic resonance imaging rating scale
Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
Outcome about Neuroimaging in preterms
general movements outcome
Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
Outcome about General Movements Assessment. Three outcomes about movement of preterm. Normal, Poor Repertoire and Cramped Synchronized
PERI outcome
Time frame: through study completion, an average of 18 months
Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Preterm
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
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.
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 and Assessment, run by University of Castilla-La Mancha at 1 site in Spain.
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 7 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: status not confirmed, as of the sponsor's last update on 29 Aug 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Merino Andrés, MsC (925268800 ext. 5822, Javier.Merino@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gestation weeks (time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks). The study lists 8 primary outcomes in all. 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 29 Aug 2019.