Validity and Reliability of Specific Test of Early Infant Motor Performance (STEP) Version 3.0

NCT05624541 | Unknown

• 1 other identifier: 09.2021.887
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Birth Complication; Cerebral Palsy; Infant, Premature, Diseases

Keywords

infant; validity and reliability; premature

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Change from the baseline of the BAYLEY-III score at corrected age 6th month of infants

Study Arms (1)

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.

Diagnostic Test: Measurements

Interventions

Measurements DIAGNOSTIC_TEST

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.

Also known as: Measurements of neurological development.

preterm Infant

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Infant, Premature, Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Evrim Karadag-Saygi, Prof

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Kübra Kurt, MSc

CONTACT

05530828032; kubrakurt110@gmail.com

Ayça Evkaya Acar, PhD

CONTACT

05544263263; aycaevkaya@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: January 18, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)