Reliability of Hammersmith Examination in Prediction of Neurological Outcomes (REHAPENO)

Study Overview
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Brief Summary
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In this study workers are trying to test the correlation between Hammersmith Infant Neurological Examination and MRI brain/cranial ultrasound with early prediction of neurological developmental outcome of preterm neonates. This study is prospective cross-sectional collecting the data of patients according to daily standard medical practice

Detailed Description
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The primary aim of this study is to evaluate the neurobehavioural performance of infants born preterm using the Hammersmith Infant Neurological Examination (HINE) in standard medical practice and compare it with the gold standard MRI and ultrasound imagings. It would be possible to check do we need to use all the 3 examinations or Hammersmith examination would be enough reliable predictor. Secondary aim is to explore the relationships between MRI brain /cranial us abnormalities and HINE at term-equivalent age in infants born preterm in prediction of neurological outcome at 1 year of chronological age. This study will be only single arm/single group. This group would receive the regular practice of MRI, Ultrasound (US) and Hammersmith assessments. The 3 assessments would be compared in relationships with the neonatal developmental outcomes (developmental milestones).

Official Title
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Reliability of Hammersmith Examination in Prediction of Neurological Outcomes In Preterm Infants - Observational Study (REHAPENO)

Conditions
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Child Development Disorders, Preterm Infant, Cerebral Palsy

Intervention / Treatment
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* Other: Correlation analyses for the outcomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants <37 weeks' GA at birth admitted to the neonatal nurseries at the Abha Private Hospital in Kingdom of Saudi Arabia. This project aims to recruit 50 infants <37weeks at birth over a 1-year stating from march 2018 Exclusion Criteria: -infants with congenital or chromosomal abnormalities
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm Infant Neurological Follow-Up<br>Preterm infants <37 weeks' gestational age (GA) at birth admitted to the neonatal nurseries at the Abha Private Hospital in Kingdom of Saudi Arabia. This project aims to recruit 50 infants <37weeks at birth over a 1-year stating from march 2018. A Correlation analyses for the outcomes with initial regular medical practice of MRI/Ultrasound and Hammersmith assessment. | Other: Correlation analyses for the outcomes<br>* No medical intervention would be done. The single arm would receive regular practice of Hammersmith Assessment and MRI / Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non inferiority of MRI to Hammersmith assessments in developmental outcomes | Hammersmith assessment will be tested for non-inferiority to gold standard assessment method by MRI in terms of sensitivity for early prediction of delayed neurological syndrome (DNS) | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority testing for Hammersmith assessment to gold standard MRI | Testing the superiority of Hammersmith assessment versus gold standard MRI in terms sensitivity for early prediction of DNS | 12 month | 
| Comparing the correlations of MRI and US scans with early prediction of DNS | Comparing the correlations of MRI and US scans with the early prediction of DNS | 12 month | 
| Comparing the correlations of US scan and Hammersmith assessment | Comparing the correlations of US scan and Hammersmith assessment with the early prediction of DNS | 12 month | 
| Hammersmith health economic analyses if primary endpoint is achieved | Both cost minimization analyses and cost effective analyses would be applied | 12 month | 
| Specificity and sensitivity for all techniques MRI, US and Hammersmith | Calculations for specificity and sensitivity would be applied for MRI, US and Hammersmith | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm, Child Development Disorders, Hammersmith, neurological outcomes, epidemiology