Clinical trial NCT03580252: Reliability of Hammersmith Examination in Prediction of Neurological Outcomes (REHAPENO)
Official title: Reliability of Hammersmith Examination in Prediction of Neurological Outcomes In Preterm Infants - Observational Study (REHAPENO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development Disorders
Preterm Infant
Cerebral Palsy
Keywords: preterm
Child Development Disorders
Hammersmith
neurological outcomes
epidemiology
Lead sponsor: Abha International Private Hospital
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Non inferiority of MRI to Hammersmith assessments in developmental outcomes
timeFrame: 12 month
Secondary outcomes:
measure: Superiority testing for Hammersmith assessment to gold standard MRI
timeFrame: 12 month
measure: Comparing the correlations of MRI and US scans with early prediction of DNS
timeFrame: 12 month
measure: Comparing the correlations of US scan and Hammersmith assessment
timeFrame: 12 month
measure: Hammersmith health economic analyses if primary endpoint is achieved
timeFrame: 12 month
measure: Specificity and sensitivity for all techniques MRI, US and Hammersmith
timeFrame: 12 month
Other outcomes:
Locations:
city: Abha
country: Saudi Arabia
facility: Abha Private Hospital
Study officials:
affiliation: College of Medicine, Mansoura University
name: Mohamed Fleifel, MD MSc PhD
role: STUDY_CHAIR
affiliation: College of Medicine, Al Azhar University
name: Rawya Abdelghani, MD MSc PhD
role: STUDY_DIRECTOR
affiliation: IQVIA Switzerland
name: Mohamed Ameen, MICR RPh
role: PRINCIPAL_INVESTIGATOR
References: