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Floppy InfantNCT06183996

Patterns Of Floppy Infants Attending Assiut University Children Hospital

An observational study of Floppy Infant, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Floppy Infant includes a variety of signs and symptoms: hypotonia, weakness and ligamentous laxity and increased range of joint mobility. Based on clinical criteria hypotonia can be classified in two major groups: central and peripheral hypotonia .The primary objective of the diagnosis is to enable an early… Read more about this study

Who is it for?
Ages Up to 12 months
Conditions the study is for
Floppy Infant
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jan 2024to 1 Jan 2026
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 12 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: Infants presented by generalized hypotonia and hyporeflexia

Who may be able to join

  • Infants presented by generalized hypotonia and hyporeflexia

Who cannot join

  • Infants with global developmental delay \& Central causes of hypotonia

Trial locations and contacts

No sites are listed yet.

christina sameh, Assistant Lecturer contact

01273341280

Christinasameh4@gmail.con

About this study

The Floppy Infant includes a variety of signs and symptoms: hypotonia, weakness and ligamentous laxity and increased range of joint mobility. Based on clinical criteria hypotonia can be classified in two major groups: central and peripheral hypotonia .The primary objective of the diagnosis is to enable an early identification of the problem to start an effective supportive therapy. Also allows formulating a more accurate prognosis. Last, the identification of forms of neonatal hypotonia with familial transmission is crucial for genetic counseling for future pregnancies.etiology in hypotonic infants is necessary for prognosis prediction and treatment. History taking and physical examination should be supported by the laboratory tests and neuroimaging methods. However, diversity may require a genetic diagnosis.

Read the detailed description

The Floppy Infant includes a variety of signs and symptoms: decrease in muscle tone (hypotonia), in muscle power (weakness) and ligamentous laxity and increased range of joint mobility. Based on clinical criteria hypotonia can be classified in two major groups: central hypotonia and peripheral hypotonia .

Hypotonia is defined as poor muscle tone in the muscles of the trunk, limbs and face. This means that the muscles provide little resistance when someone else is passively moving them. Hypotonia can be categorized as axial or truncal ,predominantly affecting the neck and spinal muscles; appendicular, affecting predominantly the extremities; or global, affecting the entire body. It is identified early in life when the newborn is unable to obtain a normal posture during movements or at rest.

Regardless of whether the underlying cause of hypotonia is peripheral or central in origin, the presentation of floppy infant syndrome focuses on observing for the presence or absence of specific signs such as 'frog-leg' posture, significant head lag on traction or pull-to-sit maneuver, or the feeling of 'slipping through the hands' when the infant is held under the arms.

The primary objective of the diagnosis is to enable, where possible, an early identification of the problem to start an effective supportive therapy. A precise etiological diagnosis also allows formulating a more accurate prognosis. Last but not least, the identification of forms of neonatal hypotonia with familial transmission is crucial for the formulation of a genetic counseling for future pregnancies.

Inspite of the advances in laboratory diagnosis and imaging, multidisciplinary evaluation by different specialties including genetics, metabolics , pediatric neurology and pediatric neuroradiology is mandatory .

sometimes, the etiology cannot be found. Although it is difficult to define the underlying etiology in hypotonic infants, it is necessary to know the etiology for prognosis prediction and treatment. History taking and physical examination should be supported by the laboratory tests and neuroimaging methods. However, diversity may require a genetic diagnosis

Conditions
Floppy Infant
Medical subject headings
Muscle Hypotonia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patterns Of Floppy Infants Attending Assiut University Children's Hospital

    Evaluate the percentage of floppy infants with peripheral causes in relation to the whole cases of floppy infants attending Assiut university children hospital

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2023
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

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
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06183996
Sponsor's protocol ID
CS
Status last verified
Dec 2023
First submitted
14 Dec 2023
Last updated
28 Dec 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Floppy Infant, 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 Dec 2023. 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 christina sameh, Assistant Lecturer (01273341280, Christinasameh4@gmail.con), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patterns Of Floppy Infants Attending Assiut University Children's Hospital (time frame: 2 years). 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 Dec 2023.

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