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

NCT05217199 | Completed

• 1 other identifier: KSU3
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant Development; Sensory Disorder; Sensory Processing Disorder; Motor Delay; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Infant Asphyxia; Development Delay

Keywords

Motor development; Sensory development; High risk of Infants; Sensry disorder

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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

Study Arms (1)

1/high risk of infants for cp

1/ high risk of infants for cp was evaulated.

Other: Measurements

Interventions

Measurements OTHER

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.

1/high risk of infants for cp

Eligibility Criteria

• Age: 25 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

High risk of infants and healty peer aged control group

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Hatice Adıgüzel

Kahramanmaraş, Dulkadiroglu, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sensation Disorders; Psychomotor Disorders; Infant, Premature, Diseases; Learning Disabilities

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Communication Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• hatice adıgüzel, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 1, 2022
• Study Start: April 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: August 15, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)