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

NCT03580252 | Completed

• 1 other identifier: Fleifel001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Child Development Disorders; Preterm Infant; Cerebral Palsy

Keywords

preterm; Child Development Disorders; Hammersmith; neurological outcomes; epidemiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Superiority testing for Hammersmith assessment to gold standard MRI

  12 month

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

  12 month

• Comparing the correlations of US scan and Hammersmith assessment

  12 month

• Hammersmith health economic analyses if primary endpoint is achieved

  12 month

• Specificity and sensitivity for all techniques MRI, US and Hammersmith

  12 month

Study Arms (1)

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.

Other: Correlation analyses for the outcomes

Interventions

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

Preterm Infant Neurological Follow-Up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• infants with congenital or chromosomal abnormalities

Sponsors & Collaborators

• Abha International Private Hospital: lead

Study Sites (1)

Abha Private Hospital

Abhā, 7415, Saudi Arabia

Location

MeSH Terms

Conditions

Developmental Disabilities; Premature Birth; Cerebral Palsy

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mohamed Fleifel, MD MSc PhD

  College of Medicine, Mansoura University

  STUDY CHAIR

• Rawya Abdelghani, MD MSc PhD

  College of Medicine, Al Azhar University

  STUDY DIRECTOR

• Mohamed Ameen, MICR RPh

  IQVIA Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: July 9, 2018
• Study Start: March 1, 2018
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

SA (1)