IRON DEFICIENCY ANEMIA IN RELATION TO PINCH STRENGTH AND HAND DEXTERITY IN PRESCHOOL CHILDREN (IDA)

July 15, 2023 updated by: Fatma Essam ELDIN ABDALLAH AMER, Cairo University

Anemia is a major public health problem among preschool-aged children. The evidence demonstrated that early childhood anemia is a strong predictor of adulthood anemia (Gessner, 2009). According to Egypt's Demographic and Health Survey (EDHS), prevalence rates of anemia in children aged 6-59 months ranged from 23% to 45% (EDHS, 2014). It is assumed that 50% of the cases of anemia are due to ID (Aref and Khalifa, 2019). The major health problem in Egypt is ID that affects 41.2% of children aged <5years (El-Asheer et al., 2021). The total prevalence of IDA in the Nile Delta region was 17.19% of the children (El-Shanshory et al., 2021). Iron is a trace element that is essential to form hemoglobin in red blood cells and to carry oxygen to peripheral tissues. In addition, iron plays essential functions in the mitochondria, which are crucial for regulating energy metabolism in the skeletal muscle (Kang and Li, 2012). And low iron levels limit oxygen bioavailability in the peripheral tissues, including skeletal muscle (Jolly et al., 2001).Yu-mi et al., (2020) found a low handgrip strength in anemic patients. Also, ID can impaired brain energy metabolism, along with hypo-myelination and impaired dopamine signaling, is consistently described as one of the mechanistic causes of the neurodevelopmental deficits associated with early-life ID (Thomas et al., 2020).

HYPOTHESES:

There is a relation between IDA and pinch strength and hand dexterity in preschool children.

RESEARCH QUESTION:

Is there a relation between IDA and pinch strength and hand dexterity in preschool children?

The purpose of the current study is to find the relation between IDA and:

  1. Pinch grip strength (tripod and tip to tip grip strength).
  2. Hand dexterity in preschool children.

Study Overview

Status

Completed

Detailed Description

i. Instrumentations for selection:

  1. Fully automated blood cell counter. A complete blood count (CBC) is one of the most commonly and routinely done laboratory tests It will be obtained through the use of fully automated blood cell counter (sysmex-Xs 800i).
  2. Beckman coulter-AU 480- blood chemistry auto-analyzer. It is the ideal primary chemistry analyzer for measurement of the amount of serum iron in the blood. ii. Instrumentations for assessment:

Updated 23/11/12

4

  1. Baseline mechanical Pinch gauge (0-60 lb.) used to measure tripod pinch strength of dominance and non-dominance hands for all participated children.
  2. Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) The Bruininks-Oseretsky Test of Motor Proficiency is a standardized, norm-referenced measure

Inclusion Criteria:

  1. Their age will be ranged from 5-6 years
  2. The fifty anemic children will have microcytic hypochromic anemia: their Hb < 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level

    <12 µg/L for children in absence of infection (WHO, 2017). ( Appendix I).

  3. They will be right handed.
  4. They had no history of previous hand injuries, surgeries or other functional hand limitation.
  5. All children will able to follow instructions and understand commands given during test procedures.
  6. Their body mass index (BMI) will be ranged from 15.2 to 15.5 kg/m2 (WHO, 2007). (Appendix II).

B. Exclusion Criteria:

Children will exclude if they have:

  1. Congenital or acquired deformity in the joints of upper limb.
  2. Unhealed fracture in upper limb bones.
  3. Systematic disease that cause anemia such as renal or hepatic failure or a history of bone disease.
  4. Blood transfusion within 3 months before measuring the hematological indices.
  5. Documented trauma in the previous 12 months in the muscle fibers, or those taking medication that affecting strength.
  6. Children begin with musculoskeletal problems or neurological disorders that affected their upper extremities

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

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

Study Locations

      • Zagazig, Egypt, 055
        • the Outpatient Clinic of Pediatrics, Zagazig University Hospitals.

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

N/A

Sampling Method

Non-Probability Sample

Study Population

eighty seven children from both sexes ranging in age from 5-6 years (thirty sex non-anemic children and fifty children with IDA (subdivided in to two equal groups. Group (I) 25 children with mild IDA and group (II) 25 children with moderate IDA). 2. They will be selected from the Outpatient Clinic of Pediatrics, Zagazig University Hospitals.

3. The fifty anemic children will have microcytic hypochromic anemia:. for children aged 5-11 years old, Hb < 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level <12 µg/L for children in absence of infection (WHO, 2017).

Description

Inclusion Criteria

  1. Their age will be ranged from 5-6 years
  2. The fifty anemic children will have microcytic hypochromic anemia: their Hb < 11.5 g/L (Hb from 11.0-11.4 is mild anemia and in moderate anemia Hb is from 8.0-10.9 (WHO, 2011). The serum iron is below 60 mcg/dL (Elngar et al., 2021). The Ferritin level

    <12 µg/L for children in absence of infection (WHO, 2017). ( Appendix I).

  3. They will be right handed.
  4. They had no history of previous hand injuries, surgeries or other functional hand limitation.
  5. All children will able to follow instructions and understand commands given during test procedures.
  6. Their body mass index (BMI) will be ranged from 15.2 to 15.5 kg/m2 (WHO, 2007). (Appendix II).

Exclusion Criteria:

  • Children will exclude if they have:

    1. Congenital or acquired deformity in the joints of upper limb.
    2. Unhealed fracture in upper limb bones.
    3. Systematic disease that cause anemia such as renal or hepatic failure or a history of bone disease.
    4. Blood transfusion within 3 months before measuring the hematological indices.
    5. Documented trauma in the previous 12 months in the muscle fibers, or those taking medication that affecting strength.
    6. Children begin with musculoskeletal problems or neurological disorders that affected their upper extremities
    7. Children who practice in any regular sport activities involving the upper extremities.8)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A
group (A) thirty-six non-anemic children
  1. Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer (Beckman Coulter Diagnostics-USA) was used for measurement of hemoglobin and serum iron levels
  2. Chemiluminescence assay using an Abbott i2000SR analyser was used to measured serum ferritin
Other Names:
  • measure tip to tip and tripod pinch strength by Baseline mechanical Pinch gauge (0-60 lb.) and BOT-2 used to assess manual dexterity
group B
group (B) twenty five children with mild IDA
  1. Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer (Beckman Coulter Diagnostics-USA) was used for measurement of hemoglobin and serum iron levels
  2. Chemiluminescence assay using an Abbott i2000SR analyser was used to measured serum ferritin
Other Names:
  • measure tip to tip and tripod pinch strength by Baseline mechanical Pinch gauge (0-60 lb.) and BOT-2 used to assess manual dexterity
Group C
group (C) 26 children with moderate
  1. Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer (Beckman Coulter Diagnostics-USA) was used for measurement of hemoglobin and serum iron levels
  2. Chemiluminescence assay using an Abbott i2000SR analyser was used to measured serum ferritin
Other Names:
  • measure tip to tip and tripod pinch strength by Baseline mechanical Pinch gauge (0-60 lb.) and BOT-2 used to assess manual dexterity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure tip to tip and tripod pinch strength
Time Frame: one year
Baseline mechanical Pinch gauge (0-60 lb.) used to measure tip to tip and tripod pinch strength for all participated children
one year
manual dexterity
Time Frame: one year
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
one year
hemoglobin and serum iron levels
Time Frame: one year
Fully automated blood cell counter (sysmex-Xs 800i) and AU 480-Chemistry auto-analyzer
one year

Collaborators and Investigators

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

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 (Actual)

May 20, 2022

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

July 15, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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