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.
Investigators
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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