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

NCT ID: NCT03580252

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-01-25

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).

Conditions

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Child Development Disorders Preterm Infant Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm Infant Neurological Follow-Up

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.

Correlation analyses for the outcomes

Intervention Type OTHER

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

Interventions

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Correlation analyses for the outcomes

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

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abha International Private Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Fleifel, MD MSc PhD

Role: STUDY_CHAIR

College of Medicine, Mansoura University

Rawya Abdelghani, MD MSc PhD

Role: STUDY_DIRECTOR

College of Medicine, Al Azhar University

Mohamed Ameen, MICR RPh

Role: PRINCIPAL_INVESTIGATOR

IQVIA Switzerland

Locations

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Abha Private Hospital

Abhā, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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Fleifel001

Identifier Type: -

Identifier Source: org_study_id

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