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

Cerebral Palsy Clinical Trial

— REHAPENO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580252
• Other study ID #: Fleifel001
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: January 2019
• Source: Abha International Private Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Child Development Disorders
• Developmental Disabilities
• Premature Birth
• Preterm Infant

Intervention

Other:
• Correlation analyses for the outcomes
No medical intervention would be done. The single arm would receive regular practice of Hammersmith Assessment and MRI / Ultrasound

Locations

Country	Name	City	State
Saudi Arabia	Abha Private Hospital	Abha

Sponsors (1)

Lead Sponsor	Collaborator
Abha International Private Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Hammersmith health economic analyses if primary endpoint is achieved	Both cost minimization analyses and cost effective analyses would be applied	12 month
Secondary	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