Infant DevelopmenthighriskNCT05217199
The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2
An observational study of Infant Development and Sensory Disorder, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 25 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Sensory Disorder, Sensory Processing Disorder
- What is being tested?
- Measurements
- Type of treatment
- Pill or oral medicine
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: High risk of infants and healty peer aged control group
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatice Adıgüzel
Kahramanmaraş, Dulkadiroglu, 46100
About this study
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
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.
Read the detailed 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.
- Conditions
- Infant Development, Sensory Disorder, Sensory Processing Disorder, Motor Delay, Infant, Premature, Diseases, Infant, Very Low Birth Weight
- Being tested
- Measurements
- Keywords
- Motor development, Sensory development, High risk of Infants, Sensry disorder
- Medical subject headings
- Sensation Disorders, Psychomotor Disorders, Infant, Premature, Diseases, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1/high risk of infants for cp | 1/ high risk of infants for cp was evaulated. Receives: Other: Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Measurement once at 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start15 Apr 2022
- Primary completion15 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adıgüzel, PhD, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217199
- Sponsor's protocol ID
- KSU3
- Acronym
- highrisk
- Status last verified
- Nov 2023
- First submitted
- 5 Jan 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05217199
- Acronym / sponsor ID
- highrisk / KSU3
- Conditions
- Infant Development, Sensory Disorder, Sensory Processing Disorder, Motor Delay, Infant, Premature, Diseases, Infant, Very Low Birth Weight
- Keywords
- Motor development, Sensory development, High risk of Infants, Sensry disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/high risk of infants for cp | – | Other: Measurements1/ high risk of infants for cp was evaulated. |
Who may qualify
- Ages
- 25 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- High risk of infants and healty peer aged control group
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeasurementsDemographic 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. | Other | 1/high risk of infants for cp |
Primary outcome
Infant Sensory Profile-2 (ISP-2)
Time frame: one assessment at the corrected age of 3th months.
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.
Hammersmith Infant Neurological Examination (HINE)
Time frame: one assessment at postterm corrected age of 3th months.
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.
Prechtl's General Movements Assessments (GMs)1
Time frame: Measurement at postterm age of 12tk to 20th weeks.
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.
Diagnosis of CP (neuroimaging by MRI)
Time frame: Measurement once at 2 years of age
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hatice adıgüzel, PhD principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development and Sensory Disorder, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Sensory Profile-2 (ISP-2) (time frame: one assessment at the corrected age of 3th months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.