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Completed

NCT Number: NCT03580252

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

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

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Key information

Conditions

Child Development Disorders Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Developmental Disabilities Female Urogenital Diseases and Pregnancy Complications Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Infant Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Abha Private Hospital

Abhā, 7415, Saudi Arabia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Correlation analyses for the outcomes

Other

No medical intervention would be done. The single arm would receive regular practice of Hammersmith Assessment and MRI / Ultrasound

Primary outcomes

  1. Non inferiority of MRI to Hammersmith assessments in developmental outcomes

    Time frame: 12 month

    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)

Secondary outcomes

  1. Superiority testing for Hammersmith assessment to gold standard MRI

    Time frame: 12 month

    Testing the superiority of Hammersmith assessment versus gold standard MRI in terms sensitivity for early prediction of DNS

  2. Comparing the correlations of MRI and US scans with early prediction of DNS

    Time frame: 12 month

    Comparing the correlations of MRI and US scans with the early prediction of DNS

  3. Comparing the correlations of US scan and Hammersmith assessment

    Time frame: 12 month

    Comparing the correlations of US scan and Hammersmith assessment with the early prediction of DNS

  4. Hammersmith health economic analyses if primary endpoint is achieved

    Time frame: 12 month

    Both cost minimization analyses and cost effective analyses would be applied

  5. Specificity and sensitivity for all techniques MRI, US and Hammersmith

    Time frame: 12 month

    Calculations for specificity and sensitivity would be applied for MRI, US and Hammersmith

Sponsors and collaborators

Lead sponsor

Abha International Private Hospital

Other

Registry information

Official study title

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

Acronym: REHAPENO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2018
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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