CompletedNot Applicable

Associations Between General Movements Assessments and Cognitive Development

Turkey (Türkiye)63 participantsStarted 2020-08-01

Plain-language summary

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP and learning diffuculties which can be observed in high-risk infants, is based on the combination of some neurological and clinical signs.

Who can participate

Age range

25 Weeks – 42 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Having periventricular hemorrhage, ICH stages 2, 3, 4, cystic PVL, stage 3 HIE, kernicterus, perinatal asphyxia, chronic lung disease, RDS, BPD, long-term oxygen (7 days), \>24 hours mechanical ventilator (MV) support, 5th minute Apgar Score \<3, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), gestation age \<32 weeks, and prematurity due to preterm/multiple births\<1500 gr. Exclusion Criteria: * Infants with congenital malformation (Spina Bifida, Congenital Muscular Torticollis, Arthrogriposis Multiplex Congenita etc.) * Infants diagnosed with metabolic and genetic diseases (Down Syndrome,Spinal Muscular Atrophy, Duchenne Muscular Dystrophy etc.) * Infants still intubated and mechanical ventilator dependent at postterm 3 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prechtl's General movements (GMs) assessments1

Timeframe: Measurement at preterm age (birth to 40weeks)

Prechtl's General movements (GMs) assessments2

Timeframe: Measurement between the term age to 9th weeks

Prechtl's General movements (GMs) assessments3

Timeframe: Measurement at fidgety periods of life (between 10th weeks to 20th weeks)

The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)

Timeframe: Change from the baseline of the BAYLEY-III score at 3, 6,12th month of infants

Trial details

NCT IDNCT05217056

SponsorKahramanmaras Sutcu Imam University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-08-30

View on ClinicalTrials.gov More Cerebral Palsy trials