Infant FloppyNCT03857555
Causes of Peripheral Hypotonia in Assiut University Children Hospital
An observational study of Infant Floppy, run by Assiut University.
Trial summary
Hypotonia is a common manifestation in infants and children.It includes several clinical conditions that do not always lead to a favorable outcome .Thus, it is important to make early diagnosis to decide on the treatment and follow up of these cases. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Infant Floppy
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Apr 2021
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will be conducted in the neuro-pediatric clinic at Assiut University Hospital after approval from the ethical review board.Tthirty five infant and children with peripheral hypotonia will be evaluated to reach a diagnosis
Who may be able to join
- all infant and children with peripheral hypotonia
Who cannot join
- central causes of hypotonia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Causes of Peripheral Hypotonia in Children Attending Assiut University Children Hospital
Hypotonia is a common manifestation in infants and children.It includes several clinical conditions that do not always lead to a favorable outcome .Thus, it is important to make early diagnosis to decide on the treatment and follow up of these cases. Hypotonia is a state of low muscle tone (The amount of tension or resistance to stretch on a muscle), often pointing to reduced muscle strength.
Hypotonia is not a specific medical disorder, but a potential manifestation of several diseases and disorders, that affect motor nerve control by the brain or muscle strength.
Read the detailed description
Criteria of peripheral hypotonia are : absent or depressed tendon reflexes , failure of movements on postural reflexes ,fasciculation with or without muscle atrophy .A sequential scheme of localization would begin with the anterior horn cell (AHC), and progress to the peripheral nerve , neuromuscular junction (NMJ) and the muscle itself.
Electroneuromyography (ENMG) provides useful information on many neuromuscular diseases. In addition nerve conduction study is also helpful to identify the most common peripheral disorders causing hypotonia in these children.
The initial approach to hypotonia is to determine whether the problem is due to central or peripheral origin.This is of crucial importance when forming a plan for diagnostic investigations and management.
Many muscle diseases share common clinical features that may lead to laboratory diagnosis by using enzyme levels that are affected in some of these diseases(e.g creatine phosphokinase ). However the use of serum creatine phosphokinase level may not possibly differentiate between various muscle diseases . The selective involvement of certain muscles is a key to the diagnosis of muscle disease].
High resolution ultrasound allows visualization of the muscle, nerve and adjacent structures and can offer real-time information regarding neuromuscular diseases. It can be used as a helping tool to electrodiagnosis with estimation of the serum creatine phosphokinase levels of these cases.
The aim of this work :is to give a profile of the causes of peripheral hypotonia in infant and children attending Assiut University Children Hospital during one year of the study .
Besides full clinical assessment of the cases including birth history , developmental history, age, sex, and duration of illness as well as age of onset of observed weakness will be recorded. Full neurological examination will be done in all cases .Cases will have serum creatine phosphokinase levels, electromyography and nerve conduction studies done as indicated.Cases will also have real time muscle ultrasonography done.
- Our results will be compared with the results obtained by other investigators .
- Statistical analysis : correlation studies will be done between the various methods of investigations used .Chi2 test will be used to indicate the prevalence of the various causes of hypotonia found in the study .
- Conditions
- Infant Floppy
- Medical subject headings
- Muscle Hypotonia
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect the role of combin- ing clinical and radiological assessments in the diagnosis of muscle diseases and the possibility of using muscle ultrasound as a screening tool when muscle diseases are suspected.
Muscles ultrasounds will perform using Phillips HD15000, brand ATL,model HTI 5000,and Origin USA linear probe 5_12MHz.The probe will use in a transverse plane,perpendicular to the long axis of the muscle.The muscle will examine through its whole length dynamically inspect for any spontaneous activity at rest. The following muscles will be inspected :1.anterior thigh:rectus femoris,vastus intermedius,lateral is and medial is,sartorius, and gracilis,2.posterior thigh:adductors,biceps femoris,semitendinous, semimembranosus, (c) leg:tepialis anterior,peronii, and gastrocnemius soleus.
We will employ a visual grading system to detect whether the muscles affected. Normal muscle appears with low echo_intensity divided by ecchogenic perimysium and connective tissue with speckled appearance in the transverse plane.The muscle will be considered abnormal if it shows increase ecchogenicity, lost its striation, or show change in muscle bulk.
Measured: 30 minutes,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study startApr 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant FloppyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Abouzeid Zaki, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857555
- Sponsor's protocol ID
- COPHIAUCH
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Helmy H, Aboumousa A, Abdelmagied A, Alsayyad A, Nasr SA. The role of muscle ultrasound in helping the clinical diagnosis of muscle diseases. Egypt J Neurol Psychiatr Neurosurg. 2018;54(1):29. doi: 10.1186/s41983-018-0039-6. Epub 2018 Nov 1.
PubMed 30459502Cetin E, Cuisset JM, Tiffreau V, Vallee L, Hurtevent JF, Thevenon A. The value of electromyography in the aetiological diagnosis of hypotonia in infants and toddlers. Ann Phys Rehabil Med. 2009 Sep-Oct;52(7-8):546-55. doi: 10.1016/j.rehab.2009.06.004. Epub 2009 Aug 18. English, French.
PubMed 19713169
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Peripheral Hypotonia in Children Attending Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT03857555
- Acronym / sponsor ID
- COPHIAUCH
- Conditions
- Infant Floppy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 28 Feb 2019 (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.
Hypotonia is a common manifestation in infants and children.It includes several clinical conditions that do not always lead to a favorable outcome .Thus, it is important to make early diagnosis to decide on the treatment and follow up of these cases. Hypotonia is a state of low muscle tone (The amount of tension or resistance to stretch on a muscle), often pointing to reduced muscle strength.
Hypotonia is not a specific medical disorder, but a potential manifestation of several diseases and disorders, that affect motor nerve control by the brain or muscle strength.
Detailed description
Criteria of peripheral hypotonia are : absent or depressed tendon reflexes , failure of movements on postural reflexes ,fasciculation with or without muscle atrophy .A sequential scheme of localization would begin with the anterior horn cell (AHC), and progress to the peripheral nerve , neuromuscular junction (NMJ) and the muscle itself.
Electroneuromyography (ENMG) provides useful information on many neuromuscular diseases. In addition nerve conduction study is also helpful to identify the most common peripheral disorders causing hypotonia in these children.
The initial approach to hypotonia is to determine whether the problem is due to central or peripheral origin.This is of crucial importance when forming a plan for diagnostic investigations and management.
Many muscle diseases share common clinical features that may lead to laboratory diagnosis by using enzyme levels that are affected in some of these diseases(e.g creatine phosphokinase ). However the use of serum creatine phosphokinase level may not possibly differentiate between various muscle diseases . The selective involvement of certain muscles is a key to the diagnosis of muscle disease].
High resolution ultrasound allows visualization of the muscle, nerve and adjacent structures and can offer real-time information regarding neuromuscular diseases. It can be used as a helping tool to electrodiagnosis with estimation of the serum creatine phosphokinase levels of these cases.
The aim of this work :is to give a profile of the causes of peripheral hypotonia in infant and children attending Assiut University Children Hospital during one year of the study .
Besides full clinical assessment of the cases including birth history , developmental history, age, sex, and duration of illness as well as age of onset of observed weakness will be recorded. Full neurological examination will be done in all cases .Cases will have serum creatine phosphokinase levels, electromyography and nerve conduction studies done as indicated.Cases will also have real time muscle ultrasonography done.
- Our results will be compared with the results obtained by other investigators .
- Statistical analysis : correlation studies will be done between the various methods of investigations used .Chi2 test will be used to indicate the prevalence of the various causes of hypotonia found in the study .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will be conducted in the neuro-pediatric clinic at Assiut University Hospital after approval from the ethical review board.Tthirty five infant and children with peripheral hypotonia will be evaluated to reach a diagnosis
Key inclusion criteria (1 listed)
- all infant and children with peripheral hypotonia
Key exclusion criteria (1 listed)
- central causes of hypotonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To detect the role of combin- ing clinical and radiological assessments in the diagnosis of muscle diseases and the possibility of using muscle ultrasound as a screening tool when muscle diseases are suspected.
Time frame: 30 minutes,
Muscles ultrasounds will perform using Phillips HD15000, brand ATL,model HTI 5000,and Origin USA linear probe 5_12MHz.The probe will use in a transverse plane,perpendicular to the long axis of the muscle.The muscle will examine through its whole length dynamically inspect for any spontaneous activity at rest. The following muscles will be inspected :1.anterior thigh:rectus femoris,vastus intermedius,lateral is and medial is,sartorius, and gracilis,2.posterior thigh:adductors,biceps femoris,semitendinous, semimembranosus, (c) leg:tepialis anterior,peronii, and gastrocnemius soleus. We will employ a visual grading system to detect whether the muscles affected. Normal muscle appears with low echo_intensity divided by ecchogenic perimysium and connective tissue with speckled appearance in the transverse plane.The muscle will be considered abnormal if it shows increase ecchogenicity, lost its striation, or show change in muscle bulk.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Background: PubMed 30459502Helmy H, Aboumousa A, Abdelmagied A, Alsayyad A, Nasr SA. The role of muscle ultrasound in helping the clinical diagnosis of muscle diseases. Egypt J Neurol Psychiatr Neurosurg. 2018;54(1):29. doi: 10.1186/s41983-018-0039-6. Epub 2018 Nov 1.
- Results publication: PubMed 19713169Cetin E, Cuisset JM, Tiffreau V, Vallee L, Hurtevent JF, Thevenon A. The value of electromyography in the aetiological diagnosis of hypotonia in infants and toddlers. Ann Phys Rehabil Med. 2009 Sep-Oct;52(7-8):546-55. doi: 10.1016/j.rehab.2009.06.004. Epub 2009 Aug 18. English, French.
- Individual participant dataSharing planned: Undecided
Related trials for Infant Floppy
Recruiting
Test of Aquatic Mobility of SMA Infants
Infantile Spinal Muscular Atrophy
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Floppy, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safia Eldeebb (0882060380, safia.eldeeb@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect the role of combin- ing clinical and radiological assessments in the diagnosis of muscle diseases and the possibility of using muscle ultrasound as a screening tool when muscle diseases are suspected. (time frame: 30 minutes,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857555, which also lists 2 linked publications.
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 Feb 2019.