CClinicalTrials.gg
Status unknownNCT04073836Updated Aug 29, 2019

GMA and Peri in Moderate-late Preterms

An observational study in Preterm, Assessment and Risk Factor, sponsored by University of Castilla-La Mancha. Status unknown at 1 site in Spain. Open to participants aged 32 Weeks to 36 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-29.

Sponsored by University of Castilla-La Mancha · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
32 Weeks to 36 Weeks
Sex
All
01

Study 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 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.

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Conditions studied

  • Preterm
  • Assessment
  • Risk Factor
  • Cerebral Palsy
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In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 150 is above the median of 63 across 455 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University of Castilla-La Mancha is the lead sponsor of 104 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
32 Weeks to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Subjects who were born between the week 32 + 0 days and the week 36 + 6 days

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. gestation weeks

    Premature birth week

    Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

  2. weight

    measurement, World Health Organization percentile

    Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

  3. size

    measurement, World Health Organization percentile

    Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

  4. cranial perimeter

    measurement about head, World Health Organization percentile

    Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

  5. Apgar

    Outcome about Apgar Test

    Time frame: at birth of each preterm

  6. Magnetic resonance imaging rating scale

    Outcome about Neuroimaging in preterms

    Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

  7. general movements outcome

    Outcome about General Movements Assessment. Three outcomes about movement of preterm. Normal, Poor Repertoire and Cramped Synchronized

    Time frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

  8. PERI outcome

    Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51

    Time frame: through study completion, an average of 18 months

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Study locations

1 of 1 sites recruiting
  • Javier Merino Andrés
    Toledo, 45006, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04073836
Lead sponsor
University of Castilla-La Mancha
Responsible party
Sponsor
First posted
Aug 29, 2019
Start date
Jan 1, 2019
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Aug 29, 2019

Study contacts

Javier Merino Andrés, MsC
Contact
Javier.Merino@uclm.es
925268800 ext. 5822

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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