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Pediatric Persistent Hypoglycemia Risk Factors at Sohag University Hospital

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Summary

NIH registered a new observational clinical trial (NCT07533318) at Sohag University Hospital in Egypt studying endocrine, metabolic, and genetic risk factors of pediatric persistent hypoglycemia. The study will enroll 24 pediatric patients experiencing hypoglycemia beyond the first 3 days of life. Clinical investigators conducting pediatric metabolic research should be aware of this registry entry as part of ongoing surveillance of active hypoglycemia studies.

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What changed

NIH registered a new observational clinical trial on ClinicalTrials.gov studying risk factors for pediatric persistent hypoglycemia. The study at Sohag University Hospital in Egypt will examine endocrine, metabolic, and genetic factors in neonates and children with hypoglycemia occurring beyond the first 3 days of life. No intervention is planned; the study is purely observational.

Healthcare providers and clinical investigators should note this registry entry as part of the broader landscape of active pediatric hypoglycemia research. The study contributes to understanding controversial hypoglycemia diagnostic thresholds in neonates, including varying plasma glucose values (47-50 mg/dL) used by AAP and PES for term newborns. This observational data may inform future clinical practice guidelines without imposing new compliance obligations.

Archived snapshot

Apr 16, 2026

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A Study of Endocrine, Metabolic, and Genetic Risk Factors of Pediatric Persistent Hypoglycemia at Sohag University Hospital

Observational NCT07533318 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

Glucose is the key metabolic substrate for tissue energy production. In the perinatal period, the mother supplies glucose to the fetus, and for most of the gestational period, the normal lower limit of fetal glucose concentration is around 54 mg/dl (3 mmol/L)(1). During the first 24-48 hours of life, as normal neonates transition from intrauterine to extrauterine life, their plasma glucose (PG) concentrations are typically lower than later in life (2). Distinguishing between transitional neonatal glucose regulation in normal newborns and hypoglycemia that persists or occurs for the first time beyond the first 3 days of life is important for prompt diagnosis and effective treatment to avoid serious consequences, including seizures and permanent brain injury (2) The definition of hypoglycemia remains controversial in neonates and children. Some approaches define hypoglycemia on the basis of symptoms, others on the PG value. According to the American Academy of Pediatrics (AAP) and Pediatric Endocrine Society (PES), hypoglycemia is diagnosed when plasma glucose is, respectively, <47 mg/dL and <50 mg/dL in at term newborns during the first 48 h of life. Different threshold values have been proposed for pre-term infants (3,4) .

In at-term newborns after the first 48 h of life, infants and younger children, hypoglycemia is defined when plasma glucose is <50 mg/dL. This threshold value is low enough to avoid false-positive results, but is unlikely to lead to permanent neurolo...

Conditions: Hypoglycaemia

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533318
Docket
NCT07533318

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Metabolic disorder research Pediatric study enrollment
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Healthcare Clinical Research

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