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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Preterm Infant; Child Development Disorders
• Intervention / Treatment: Other: Correlation analyses for the outcomes

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Saudi Arabia
  • Abha, Saudi Arabia, 7415
    • Abha Private Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Hammersmith health economic analyses if primary endpoint is achieved	Both cost minimization analyses and cost effective analyses would be applied	12 month
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

Collaborators and Investigators

• Sponsor: Abha International Private Hospital
• Investigators: Study Chair: Mohamed Fleifel, MD MSc PhD, College of Medicine, Mansoura University; Study Director: Rawya Abdelghani, MD MSc PhD, College of Medicine, Al Azhar University; Principal Investigator: Mohamed Ameen, MICR RPh, IQVIA Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: preterm; epidemiology; Child Development Disorders; Hammersmith; neurological outcomes
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Neurodevelopmental Disorders; Cerebral Palsy; Premature Birth; Developmental Disabilities
• Other Study ID Numbers: Fleifel001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No