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

Infant Development Clinical Trial

— highrisk  

Official title:

The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2 in Prediction of Cerebral Palsy at Two Years of Age in High-Risk Infants: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217199
• Other study ID #: KSU3
• Status: Completed
• Start date: April 15, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: November 2023
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Weeks to 42 Weeks

Eligibility

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 Syndrome, Spinal Muscular Atrophy, Duchenne Muscular Dystrophy.)
• Babies who are still intubated and dependent on MV at postterm 3 months
• Babies with hearing and vision loss

Related Conditions & MeSH terms

• Asphyxia
• Birth Weight
• Development Delay
• Infant Asphyxia
• Infant Development
• Infant, Premature, Diseases
• Infant, Very Low Birth Weight
• Motor Delay
• Sensation Disorders
• Sensory Disorder
• Sensory Processing Disorder

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hatice Adigüzel	Kahramanmaras	Dulkadiroglu

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one assessment at the corrected age of 3th months.
Primary	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.	one assessment at postterm corrected age of 3th months.
Primary	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.	Measurement at postterm age of 12tk to 20th weeks.
Primary	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	Measurement once at 2 years of age