An observational study in Infant Development, Sensory Disorder and Sensory Processing Disorder, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey. Open to participants aged 25 Weeks to 42 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by Kahramanmaras Sutcu Imam University · Observational
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.
There are interactions between an individual's neurological thresholds and emotional and behavioral responses or self-regulation strategies. Sensory modulation is an active processing process in which the brain adapts to sensory inputs from the environment by stimulating or inhibiting neurons as required by the current situation. Based on the interaction between an individual's neurological threshold and behavioral responses, Dunn developed four different response categories. These are sensation seeking, avoidance, low registration, and increased sensory sensitivity. From infancy, these processes show appropriate development with natural stimuli. However, sometimes there may be deviations in development from early infancy. One of them is the NICU, which is necessary to support vital functions. Decreased spontaneous movements for any reason and exposure to excessive sensory stimuli in this environment may cause negative consequences for the normal sensory and motor development of the baby.Babies who stay in the NICU for a long time stay away from natural sensory stimuli. Newborn preterm infants receive less tactile and vestibular stimulation in the NICU than does prenatal maternal movement. However, they are exposed to increased stimulus with other negative stimuli such as bright lights, high noise levels, excessive use and frequent painful interventions, which are not found in the intrauterine environment in the NICU. This can have lasting effects on the developing brain and affect the natural development of sensory systems. In the studies conducted, a significant difference was found between term babies and preterm babies in terms of sensory profile scores. Studies examining the relationship between sensory processing parameters and motor development in infants are limited in the literature. There is also a need for studies examining the relationship between sensory-motor development from the neonatal period. It is thought that preterm infants are exposed to these negative sensory stimuli longer. Neurodevelopmental follow-up is required after discharge in these infants with biological sensitivity and risk of neurological injury.The aim of this study is to examine the motor and sensory development of high-risk infants and compare them with their peers.
87 studies on the registry are indexed under Sensation Disorders; 23 are open to participants now.
This study's enrollment of 34 is below the median of 58 across 25 observational studies indexed under Sensation Disorders.
Browse Sensation Disorders studies →Kahramanmaras Sutcu Imam University is the lead sponsor of 198 studies on the registry; 40 are open to participants now.
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High risk of infants and healty peer aged control group
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1/ high risk of infants for cp was evaulated.
Other: Measurements
Demographic information of infants and parents, prenatal, postnatal and natal risk factors, Magnetic Resonance Images (MRI), General Movements (GMs) evaluations of babies with Prechtl method from NICU will be recorded. Video recordings for General Movements (GMs) analyzes with the Prechtl method will be taken at postterm 12th to 20th weeks. The infants' sensory processing (general, auditory, visual, tactile, movement, oral) will be evaluated with the adjusted Infant Sensory Profile-2 (ISP-2) family scale, which will be filled in by their mothers at the 3rd month. For motor assessments, the postterm corrected 3 month Hammersmith Infant Neurological Examination (HINE) will be used. A pediatric neurologist who was blinded to all testing made the diagnosis of CP in a 2-year-old child based on neuroimaging and clinical tests.
Infant Sensory Profile-2 (ISP-2)
The Infant Sensory Profile (ISP-2) questionnaire is a 24-item questionnaire consisting of sensory profile general sensory processing score, auditory processing, visual processing score, tactile processing, motion processing, oral sensory processing sub-scores. The sensory profile raw score total score is calculated with the sum of the sub-scores. Higher scores shows better sensory functions.
Time frame: one assessment at the corrected age of 3th months.
Hammersmith Infant Neurological Examination (HINE)
The HINE is a simple, standardized, and scorable test for the clinical neurological evaluation of 2-to-24-month-old infants. It has 3 sections: (1) neurological examination (26 items, scored) evaluating cranial nerve function, posture, movements, tone, reflexes, and reactions, (2) motor milestones (8 items, unscored), and (3) behaviour (3 items, unscored). Each of the 26 items is scored first separately (as 0, 1, 2, or 3, half scores) and then the total score is calculated with a maximum score of 78. Higher score indicates good neurological function.
Time frame: one assessment at postterm corrected age of 3th months.
Prechtl's General Movements Assessments (GMs)1
General movements (GMs) are the spontaneous movement repertoire present from early foetal life until 20 weeks post-term. From birth to 8 post-term weeks, they have a "writhing" character. They will be scored as cs-pr-n-ch. From 12th to 20th weeks, they have "fidgety" character.
Time frame: Measurement at postterm age of 12tk to 20th weeks.
Diagnosis of CP (neuroimaging by MRI)
Based on neuroimaging and clinical evaluations at 2 years of age, a pediatric neurologist who was blinded to all assessments diagnosed CP. The neuroimaging scans were classified into one of seven primary patterns of abnormality as defined and described by
Time frame: Measurement once at 2 years of age
Plan to share: No
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Ran from Apr 2022 to primary completion in Jul 2023, 15 months.
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