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Assessing Neurodevelopmental outcomes of neonates with low blood sugars

To compare the neurodevelopmental outcomes of neonates with asymptomatic moderate to severe hypoglycemia vs symptomatic hypoglycemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/03/041353
Enrollment
114
Registered
2022-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: E15-E16- Other disorders of glucose regulation and pancreatic internal secretion

Interventions

None listed

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Details Neonates of gestation > 32 weeks with hypoglycemia (both symptomatic and asymptomatic) on hand held glucometer reading will be considered

Exclusion criteria

Exclusion criteria: 1) Infants with major congenital malformations 2) Infants with persistent hypoglycemia secondary to panhypopituitarism or other endocrine causes 3) Infants with inborn errors of metabolism 4) Perinatal asphyxia 5) Parents who are unwilling to give consent for follow up visit at 6-9 months of life

Design outcomes

Primary

MeasureTime frame
Neurodevelopment outcomes in symptomatic (SH) vs asymptomatic (ASH) hypoglycemia using bailey scale of infant development & ages stages questionnaireTimepoint: At 6 months and 9 to 12 months corrected age

Secondary

MeasureTime frame
(1) Mortality (2) aEEG abnormalities or changes (3) Presence of any seizure disorders (4) Vision outcomes (5) Hearing outcomes-BERA abnormalities and those on hearing aids (6) Tone abnormalities as defined by HINE score Timepoint: Total duration of NICU stay, at 6 months & 9-12 months corrected age

Countries

India

Contacts

Public ContactDr Sai kiran

fernandez hospital

drsai17@gmail.com9246847071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026