Assessing Neurodevelopmental outcomes of neonates with low blood sugars

Not yet recruiting

Conditions: Other disorders of glucose regulation and pancreatic internal secretion, ,

Registration Number: CTRI/2022/03/041353

Brief Summary: Hypoglycemia continues to be a common metabolic complicationfaced by newborns in developing countries. Both healthy and sick neonates canbe affected by hypoglycemia during the first days of life. Factors placingneonates at higher risk for developing hypoglycemia are prematurity, beingsmall or large for gestational age, perinatal stress or asphyxia, and beingborn to diabetic mothers.

Neonatal hypoglycemia is important because it is common and cancause brain damage. However, the blood glucose concentration and durationrequired to cause damage remains unclear. There was considerable variationamong the centres, implying differences in decisions to intervene. The numberof days on which moderate hypoglycemia occurred was strongly related to reducedmental and motor development scores at 18 months (corrected age), even afteradjustment for a wide range of factors known to influence development. Thereare a few retrospective studies who had done assessment of neurodevelopmentaloutcome in children who presented with epilepsy beyond infancy secondary toneonatal hypoglycemia .There has been considerable debate over whetherasymptomatic neonatal hypoglycaemia results in neurological damage.

The current study aims to compare the early adverseneurodevelopmental outcome of neonateswith asymptomatic hypoglycemia (ASH) Vs symptomatic hypoglycemia (SH) at 6& 9-12 months of corrected gestation age. Developmental assessment will bedone with Bayley Scales of Infant and Toddler Development Third Edition bysingle doctor certified in Bailey III. Composite adverse outcomes will beobserved in both the groups (SH & ASH). Apart from the developmentalassessment, we would like look into the other co morbidities associated with neonatal hypoglycemia like aEEGabnormalities, presence of seizure disorder, tone abnormalities, visionimpairment, hearing abnormalities and mortality in follow up. This is aprospective observational cohort study. Being a prospective study, it willovercome the selection bias.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 114

Inclusion Criteria

DetailsNeonates of gestation > 32 weeks with hypoglycemia (both symptomatic and asymptomatic) on hand held glucometer reading will be considered.

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurodevelopment outcomes in symptomatic (SH) vs asymptomatic (ASH) hypoglycemia using bailey scale of infant development & ages stages questionnaire	At 6 months and 9 to 12 months corrected age

Secondary Outcome Measures

Name	Time	Method
(1)Mortality	(2)aEEG abnormalities or changes

Trial Locations

Locations (1): Fernandez hospital, Hyderabad
🇮🇳
Hyderabad, TELANGANA, India
Fernandez hospital, Hyderabad
🇮🇳Hyderabad, TELANGANA, India
Dr Thiruveedi sruthi
Principal investigator
9490281522
sruthi.thiruveedi@gmail.com