CompletedNot Applicable

The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2

Turkey (Türkiye)34 participantsStarted 2022-04-15

Plain-language summary

In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus. During the critical period of brain development, this sensory overload affects the physiological responses of infants; It can lead to sensory processing problems by causing negative changes in motor, neurological and sensory development. Sensory processing was explained by Dunn as the emergence of appropriate reactions and behaviors in neurological processes in which visual, auditory, tactile, oral, olfactory, vestibular, proprioceptive and kinesthetic inputs are regulated.

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: * Term preterm babies with 0-3 months of prenatal, postnatal and natal risk who stayed in the NICU for \>2 weeks for any reason and were corrected after discharge * Babies with periventricular bleeding, ICH stage 2, 3, 4, cystic PVL, stage 3 HIE, neonatal bilirubin encephalopathy (kernicterius), perinatal stroke, perinatal asphyxia, hydrocephalus * Babies with chronic lung disease, RDS, BPD and long-term Oxygen support (≥7 days) * Preterm infants with gram-negative bacteria-associated sepsis, Necrotizing Enterocolitis (NEC), infantile apnea, cerebral malformation * Preterm babies with low 5th minute Apgar score (3 and below), diagnosed with intrauterine growth retardation, multiple births (twins, triplets), PR * Infants with prolonged severe hypoglycemia and hypocalcemia * Surgical conditions such as diaphragmatic hernia or tracheoesophageal fistula * Babies who are small for gestational age (GYB, less than 3rd percentile) or large for gestational age (GYB, greater than 97th percentile) * Babies who are MV dependent for more than 24 hours * Babies born less than 32 weeks of gestation and weighing less than 1500 g * Healthy term babies Exclusion Criteria: * \- Babies of parents who did not agree to participate in the study/Babies who did not attend follow-up evaluations * Babies with congenital malformations (Spina Bifida, Congenital Muscular Torticollis, Arthrogryposis Multiplex Congenita) * Babies diagnosed with metabolic and genetic diseases (Down Syn…

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

Infant Sensory Profile-2 (ISP-2)

Timeframe: one assessment at the corrected age of 3th months.

Hammersmith Infant Neurological Examination (HINE)

Timeframe: one assessment at postterm corrected age of 3th months.

Prechtl's General Movements Assessments (GMs)1

Timeframe: Measurement at postterm age of 12tk to 20th weeks.

Diagnosis of CP (neuroimaging by MRI)

Timeframe: Measurement once at 2 years of age

Trial details

NCT IDNCT05217199

SponsorKahramanmaras Sutcu Imam University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-15

View on ClinicalTrials.gov More Infant Development trials