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Clinical Trials/CTRI/2023/11/060330
CTRI/2023/11/060330
Not Yet Recruiting
N/A

Validation of a minimally invasive/non-invasive method for screening biomarkers of Energy metabolism disorder in clinically detected IEM children - Not applicable

Dr Saritha Kamath 0 sites0 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr Saritha Kamath
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational

Investigators

Sponsor
Dr Saritha Kamath

Eligibility Criteria

Inclusion Criteria

  • Abnormal baseline biochemical metabolic work\-up for Blood lactate, pyruvate, ammonia.
  • Criteria for abnormal (elevated) result is as follows.
  • a. Elevated lactate: pyruvate ratio: more than 25 (normal \<25\)
  • b. Elevated lactate level: more than 20 mg/dl (normal 5\-20 mg/dl)
  • c. Hyperammonaemia: more than 70 µg/dl (normal 20\-70 µg/dl)
  • ? Details of family history and clinical findings for including the patients were as follows.
  • Newborns, infants/ children below 3 years showing any of the following.
  • 1\) History of sibling deaths with similar symptoms in the absence of significant perinatal
  • 2\) Myoclonic seizures in a child with no significant perinatal insults.
  • 3\) Weak cry or poor suck at birth despite being delivered at term with no asphyxia.

Exclusion Criteria

  • Children with conditions other than IEM will be excluded.

Outcomes

Primary Outcomes

Not specified

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