Patterns Of Floppy Infants Attending Assiut University Children Hospital

December 14, 2023 updated by: Christina Sameh Youssef Ghaly, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Infants presented by generalized hypotonia and hyporeflexia

Description

Inclusion Criteria:

  • Infants presented by generalized hypotonia and hyporeflexia

Exclusion Criteria:

  • Infants with global developmental delay & Central causes of hypotonia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns Of Floppy Infants Attending Assiut University Children's Hospital
Time Frame: 2 years
Evaluate the percentage of floppy infants with peripheral causes in relation to the whole cases of floppy infants attending Assiut university children hospital
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mohamed Mahrous El Tallawy, Professor, Assiut University
  • Study Director: Eman Fathalla Gad, Assistant Professor, Assiut University
  • Study Director: Mohamed Abo bakr Mohamed, Lecturer, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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