Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05624541 |
| Other study ID # |
09.2021.887 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2022 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Marmara University |
| Contact |
Kübra Kurt, MSc |
| Phone |
05530828032 |
| Email |
kubrakurt110[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
