Preterm Birth ComplicationNCT05624541
Validity and Reliability of Specific Test of Early Infant Motor Performance (STEP) Version 3.0
An observational study of Preterm Birth Complication and Cerebral Palsy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy and other neuromotor disorders are more common in babies born preterm (<37 weeks of gestation), due to various biological and environmental risk factors and the risk increases as the gestational age decreases. Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Preterm Birth Complication, Cerebral Palsy, Infant, Premature, Diseases
- What is being tested?
- Measurements
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2022to Dec 2022
- 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 1 month to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: A total of 30 infants will be included in the study. Based on the data of the previous study, the number of participants to be included in the study was found to be correlated with G*Power 3.1.9.2 (Correlation: Bivariate) as p H1=0.89. The minimum number of individuals to be included in the sample of this study was calculated by taking effect size=0.60, α=0.05 and power=0.95, and it was found to be 30 in total. Since the effect size obtained from the sample study is large, it was preferred to use the correlation p H1=0.6 size in order to reach a larger sample size.
Who may be able to join
- Babies born before <37 weeks of gestation and treated in the neonatal intensive care unit
- Infants with neurologic abnormalities (muscle hypertonia, hypotonia, hyperarousal, and abnormal general movements or cranial ultrasound abnormalities) at moderate to high risk of cerebral palsy
- Infants referred to physiotherapy due to motor developmental delay and neurological dysfunction
- Babies whose age range is between 0-12 months (corrected age will be calculated for premature babies)
- Being diagnosed as a neurologically and developmentally risky baby
- Babies who have completed medical treatments and are not in neonatal intensive care
- Infants of families of infants who agreed to participate in the study and approved the informed consent form
Who cannot join
- Babies with congenital cyanotic heart problems or cystic fibrosis
- Babies with genetic disease or congenital anomalies
- Infants on ventilator
- Babies of families who do not accept to work
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, 34899
Kübra Kurt, MSc
Evrim Karadag-Saygi, Prof
About this study
Official title: Investigation of the Turkish Validity and Reliability of Specific Test of Early Infant Motor Performance (STEP) in Follow-Up of Risk Infants
Cerebral palsy and other neuromotor disorders are more common in babies born preterm (<37 weeks of gestation), due to various biological and environmental risk factors and the risk increases as the gestational age decreases. Earlier and more frequent screening with the use of developmental skills tests facilitates referral to early intervention programs. Current guidelines recommend using some combination of neuroimaging and neurological examination and assessments such as neonatal imaging, general movements (GMs), and Hammersmith Infant Neurological Examination (HINE) for early diagnosis and intervention.
Read the detailed description
The aim of study was to evaluate the risk of premature and low birth weight babies with the Early Infant Motor Evaluation Test (STEP), to measure the correlation of the STEP test with Bayley Infant Development Scales (Bayley-III) and Hammersmith Infant Neurological Examination (HINE) evaluations, to investigate the validity and reliability of the STEP test in the evaluation and follow-up of babies at risk.
The Early Infant Motor Evaluation Test (STEP) provides a quantitative assessment of tone and movements that allows developmental monitoring with a short screening test in terms of practical patient flow. A standardized test provides an opportunity to recognize early abnormalities in tone and movement patterns and seek treatment before milestones are delayed or abnormal movements stabilized. STEP can be used to measure early movement problems in high-risk infants, refer these infants earlier, and then monitor response to targeted interventions. It is thought that STEP can identify infants at risk of delay, thus enabling earlier initiation of targeted therapy. The implementation and scoring of STEP takes approximately 10 minutes. It does not require special training, is easy to access, is a short and fast performing neuromotor examination. As a screening test for early intervention, it can be applied in neonatal intensive care units and follow-up clinics prior to discharge, potentially improving long-term outcomes.
Technological advances in neonatal-perinatal medicine have led to a steady increase in the survival rate of preterm infants. Although the increase in survival rate has been a remarkable achievement, children born prematurely are at high risk for brain damage and long-term neurodevelopmental deficits. Premature children may have abnormal muscle tone or movements, cognitive deficits, language disorders, and behavioral problems.
Babies born preterm (<37 weeks of gestation) are three to four times more at risk for a range of motor disorders than the general population due to various biological and environmental risk factors. This highlights the need for improved surveillance and intervention strategies in this group of children.
The main goal of developmental surveillance in infants with risk factors for cerebral palsy and other neuromotor disorders is to screen for signs of delayed motor development so that physical therapy can be started as early as possible. Neuroimaging is expensive and does not detect all infants at high risk. Parental reporting of motor milestones in the first trimester is unlikely to be as accurate as methods based on direct observation. Barriers to implementing highly sensitive assessments based on direct observation include the cost of training, lack of reliability in various professions, and the duration of assessment. Most of the screening tests used involve long-term use that may harm newborns.
Accurate assessment of motor performance in infants born prematurely or with other perinatal complications requires the use of validated tests to identify delay or neurological impairment. Documenting the construct validity of a new assessment requires research that demonstrates its relevance to other tests available for similar purposes.
Recent studies also advocate the use of a combination of assessment tools in the first year of life. Studies have proven that the use of a combination of standard neurologic and motor assessments for early diagnosis and intervention in the evaluation of at-risk infants is more effective.
It is known that the STEP test does not require certification training and whose reliability is valid, does not have a Turkish version.In this thesis, the validity and reliability of the Early Infant Motor Evaluation Test (STEP) will be investigated, and its correlation with the Hammersmith Infant Neurological Examination (HINE) and Bayley Infant Development Scales (Bayley-III) evaluation will be evaluated. The translation of the scale into Turkish will be carried out separately by two health professionals who are fluent in the original language and medical terminology. The final version of the scale will be translated back from the target language to the original language by a sworn translator who has no knowledge of the subject, and the back translation will be compared with the original questionnaire.
Medical records and demographic data of the patients whose verbal and written consents were obtained will be obtained and STEP test will be applied at term age and at 3 months, with HINE test at corrected 3 months and 6 months and Bayley III test at corrected 6 month.
- Being tested
- Measurements
- Keywords
- infant, validity and reliability, premature
- Medical subject headings
- Cerebral Palsy, Infant, Premature, Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementsDiagnostic test
Also called Measurements of neurological development.
All infants at high risk of cp will be assessed by Specific Test of Early Infant Motor Performance (STEP) Version 3.0 at term age and at corrected age 3 months, by Hammersmith Infant Neurological Examination (HINE) a corrected age 3 and 6 months, also BAYLEY-III Infant and Toddler Development Assessment Scale (BAYLEY-III) at corrected 6 months.
| Study group | Role | What they receive |
|---|---|---|
| preterm Infant | 30 premature infants with a gestational age of 37 weeks and below and a history of stay in the neonatal intensive care unit will be evaluated. Receives: Diagnostic Test: Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Test of Early Infant Motor Performance (STEP) Version 3.0
The STEP test is a 10-item neurodevelopmental assessment that does not require special training, evaluating infants from term to corrected 3 months for rapid and early detection of motor problems. It evaluates the infant not only by the presence or absence of motor skills, but by the quality of movement. A term cut-off score of 16 or less and a three-month cut-off score of 22 or less are important criteria in developmental delay.
Measured: Change from term age of infants (40 weeks) to 3 month
Hammersmith Infant Neurological examination (HINE)
It is a neurodevelopmental assessment test accessible to all clinicians used for infants 2 to 24 months old. It is a 26-item test with a maximum score of 78 scored between 0-3. 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). Higher score indicates good neurological function.
Measured: Change from the baseline of the HINE score at corrected age 3, 6th month of infants
Bayley Scales of Infant and Toddler Development (BSID -III)
It is applied to evaluate the development in cognitive, language and movement areas in children whose corrected age is between 0-42 months. Movement scale consists of two parts as fine motor and gross motor. A score below 70 is a criterion for developmental delay.
Measured: Change from the baseline of the BAYLEY-III score at corrected age 6th month of infants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start18 Jan 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Birth ComplicationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Karadag-Saygi, Prof, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624541
- Sponsor's protocol ID
- 09.2021.887
- Status last verified
- Oct 2022
- First submitted
- 14 Nov 2022
- Last updated
- 27 Dec 2022
- 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 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Turkish Validity and Reliability of Specific Test of Early Infant Motor Performance (STEP) in Follow-Up of Risk Infants
- ClinicalTrials.gov ID
- NCT05624541
- Acronym / sponsor ID
- 09.2021.887
- Keywords
- infant, validity and reliability, premature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Nov 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.
Cerebral palsy and other neuromotor disorders are more common in babies born preterm (<37 weeks of gestation), due to various biological and environmental risk factors and the risk increases as the gestational age decreases. Earlier and more frequent screening with the use of developmental skills tests facilitates referral to early intervention programs. Current guidelines recommend using some combination of neuroimaging and neurological examination and assessments such as neonatal imaging, general movements (GMs), and Hammersmith Infant Neurological Examination (HINE) for early diagnosis and intervention.
Detailed description
The aim of study was to evaluate the risk of premature and low birth weight babies with the Early Infant Motor Evaluation Test (STEP), to measure the correlation of the STEP test with Bayley Infant Development Scales (Bayley-III) and Hammersmith Infant Neurological Examination (HINE) evaluations, to investigate the validity and reliability of the STEP test in the evaluation and follow-up of babies at risk.
The Early Infant Motor Evaluation Test (STEP) provides a quantitative assessment of tone and movements that allows developmental monitoring with a short screening test in terms of practical patient flow. A standardized test provides an opportunity to recognize early abnormalities in tone and movement patterns and seek treatment before milestones are delayed or abnormal movements stabilized. STEP can be used to measure early movement problems in high-risk infants, refer these infants earlier, and then monitor response to targeted interventions. It is thought that STEP can identify infants at risk of delay, thus enabling earlier initiation of targeted therapy. The implementation and scoring of STEP takes approximately 10 minutes. It does not require special training, is easy to access, is a short and fast performing neuromotor examination. As a screening test for early intervention, it can be applied in neonatal intensive care units and follow-up clinics prior to discharge, potentially improving long-term outcomes.
Technological advances in neonatal-perinatal medicine have led to a steady increase in the survival rate of preterm infants. Although the increase in survival rate has been a remarkable achievement, children born prematurely are at high risk for brain damage and long-term neurodevelopmental deficits. Premature children may have abnormal muscle tone or movements, cognitive deficits, language disorders, and behavioral problems.
Babies born preterm (<37 weeks of gestation) are three to four times more at risk for a range of motor disorders than the general population due to various biological and environmental risk factors. This highlights the need for improved surveillance and intervention strategies in this group of children.
The main goal of developmental surveillance in infants with risk factors for cerebral palsy and other neuromotor disorders is to screen for signs of delayed motor development so that physical therapy can be started as early as possible. Neuroimaging is expensive and does not detect all infants at high risk. Parental reporting of motor milestones in the first trimester is unlikely to be as accurate as methods based on direct observation. Barriers to implementing highly sensitive assessments based on direct observation include the cost of training, lack of reliability in various professions, and the duration of assessment. Most of the screening tests used involve long-term use that may harm newborns.
Accurate assessment of motor performance in infants born prematurely or with other perinatal complications requires the use of validated tests to identify delay or neurological impairment. Documenting the construct validity of a new assessment requires research that demonstrates its relevance to other tests available for similar purposes.
Recent studies also advocate the use of a combination of assessment tools in the first year of life. Studies have proven that the use of a combination of standard neurologic and motor assessments for early diagnosis and intervention in the evaluation of at-risk infants is more effective.
It is known that the STEP test does not require certification training and whose reliability is valid, does not have a Turkish version.In this thesis, the validity and reliability of the Early Infant Motor Evaluation Test (STEP) will be investigated, and its correlation with the Hammersmith Infant Neurological Examination (HINE) and Bayley Infant Development Scales (Bayley-III) evaluation will be evaluated. The translation of the scale into Turkish will be carried out separately by two health professionals who are fluent in the original language and medical terminology. The final version of the scale will be translated back from the target language to the original language by a sworn translator who has no knowledge of the subject, and the back translation will be compared with the original questionnaire.
Medical records and demographic data of the patients whose verbal and written consents were obtained will be obtained and STEP test will be applied at term age and at 3 months, with HINE test at corrected 3 months and 6 months and Bayley III test at corrected 6 month.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preterm Infant | – | Diagnostic Test: Measurements30 premature infants with a gestational age of 37 weeks and below and a history of stay in the neonatal intensive care unit will be evaluated. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A total of 30 infants will be included in the study. Based on the data of the previous study, the number of participants to be included in the study was found to be correlated with G*Power 3.1.9.2 (Correlation: Bivariate) as p H1=0.89. The minimum number of individuals to be included in the sample of this study was calculated by taking effect size=0.60, α=0.05 and power=0.95, and it was found to be 30 in total. Since the effect size obtained from the sample study is large, it was preferred to use the correlation p H1=0.6 size in order to reach a larger sample size.
Key inclusion criteria (7 listed)
- Babies born before <37 weeks of gestation and treated in the neonatal intensive care unit
- Infants with neurologic abnormalities (muscle hypertonia, hypotonia, hyperarousal, and abnormal general movements or cranial ultrasound abnormalities) at moderate to high risk of cerebral palsy
- Infants referred to physiotherapy due to motor developmental delay and neurological dysfunction
- Babies whose age range is between 0-12 months (corrected age will be calculated for premature babies)
- Being diagnosed as a neurologically and developmentally risky baby
Key exclusion criteria (4 listed)
- Babies with congenital cyanotic heart problems or cystic fibrosis
- Babies with genetic disease or congenital anomalies
- Infants on ventilator
- Babies of families who do not accept to work
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 |
|---|---|---|
| MeasurementsAlso: Measurements of neurological development.All infants at high risk of cp will be assessed by Specific Test of Early Infant Motor Performance (STEP) Version 3.0 at term age and at corrected age 3 months, by Hammersmith Infant Neurological Examination (HINE) a corrected age 3 and 6 months, also BAYLEY-III Infant and Toddler Development Assessment Scale (BAYLEY-III) at corrected 6 months. | Diagnostic test | preterm Infant |
Primary outcome
Specific Test of Early Infant Motor Performance (STEP) Version 3.0
Time frame: Change from term age of infants (40 weeks) to 3 month
The STEP test is a 10-item neurodevelopmental assessment that does not require special training, evaluating infants from term to corrected 3 months for rapid and early detection of motor problems. It evaluates the infant not only by the presence or absence of motor skills, but by the quality of movement. A term cut-off score of 16 or less and a three-month cut-off score of 22 or less are important criteria in developmental delay.
Hammersmith Infant Neurological examination (HINE)
Time frame: Change from the baseline of the HINE score at corrected age 3, 6th month of infants
It is a neurodevelopmental assessment test accessible to all clinicians used for infants 2 to 24 months old. It is a 26-item test with a maximum score of 78 scored between 0-3. 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). Higher score indicates good neurological function.
Bayley Scales of Infant and Toddler Development (BSID -III)
Time frame: Change from the baseline of the BAYLEY-III score at corrected age 6th month of infants
It is applied to evaluate the development in cognitive, language and movement areas in children whose corrected age is between 0-42 months. Movement scale consists of two parts as fine motor and gross motor. A score below 70 is a criterion for developmental delay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- 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.
Evrim Karadag-Saygi, Prof study director
Marmara 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 Preterm Birth Complication and Cerebral Palsy, run by Marmara 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kübra Kurt, MSc (05530828032, kubrakurt110@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Test of Early Infant Motor Performance (STEP) Version 3.0 (time frame: Change from term age of infants (40 weeks) to 3 month). The study lists 3 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 27 Dec 2022.