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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03580252
Other study ID # Fleifel001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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