Child Development DisordersREHAPENONCT03580252
Reliability of Hammersmith Examination in Prediction of Neurological Outcomes (REHAPENO)
An observational study of Child Development Disorders and Preterm Infant, run by Abha International Private Hospital at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child Development Disorders, Preterm Infant, Cerebral Palsy
- What is being tested?
- Correlation analyses for the outcomes
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2018to 25 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- -infants with congenital or chromosomal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- Child Development Disorders, Preterm Infant, Cerebral Palsy
- Being tested
- Correlation analyses for the outcomes
- Keywords
- preterm, Child Development Disorders, Hammersmith, neurological outcomes, epidemiology
- Medical subject headings
- Developmental Disabilities, Premature Birth, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlation analyses for the outcomesOther
No medical intervention would be done. The single arm would receive regular practice of Hammersmith Assessment and MRI / Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Correlation analyses for the outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 month
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 12 month
Hammersmith health economic analyses if primary endpoint is achieved
Both cost minimization analyses and cost effective analyses would be applied
Measured: 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
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Mar 2018
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abha International Private Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Fleifel, MD MSc PhD, Study chair, College of Medicine, Mansoura UniversityRawya Abdelghani, MD MSc PhD, Study director, College of Medicine, Al Azhar UniversityMohamed Ameen, MICR RPh, Principal investigator, IQVIA Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580252
- Sponsor's protocol ID
- Fleifel001
- Acronym
- REHAPENO
- Status last verified
- Jan 2019
- First submitted
- 19 Apr 2018
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Hammersmith Examination in Prediction of Neurological Outcomes In Preterm Infants - Observational Study (REHAPENO)
- ClinicalTrials.gov ID
- NCT03580252
- Acronym / sponsor ID
- REHAPENO / Fleifel001
- Conditions
- Child Development Disorders, Preterm Infant, Cerebral Palsy
- Keywords
- preterm, Child Development Disorders, Hammersmith, neurological outcomes, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abha International Private HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm Infant Neurological Follow-Up | – | Other: Correlation analyses for the outcomesPreterm 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- -infants with congenital or chromosomal abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correlation analyses for the outcomesNo medical intervention would be done. The single arm would receive regular practice of Hammersmith Assessment and MRI / Ultrasound | Other | Preterm Infant Neurological Follow-Up |
Primary outcome
Non inferiority of MRI to Hammersmith assessments in developmental outcomes
Time frame: 12 month
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)
5 secondary outcomes
Superiority testing for Hammersmith assessment to gold standard MRI
Time frame: 12 month
Comparing the correlations of MRI and US scans with early prediction of DNS
Time frame: 12 month
Comparing the correlations of US scan and Hammersmith assessment
Time frame: 12 month
Hammersmith health economic analyses if primary endpoint is achieved
Time frame: 12 month
Specificity and sensitivity for all techniques MRI, US and Hammersmith
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Fleifel, MD MSc PhD study chair
College of Medicine, Mansoura University
Rawya Abdelghani, MD MSc PhD study director
College of Medicine, Al Azhar University
Mohamed Ameen, MICR RPh principal investigator
IQVIA Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development Disorders and Preterm Infant, run by Abha International Private Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non inferiority of MRI to Hammersmith assessments in developmental outcomes (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.