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CTRI Number  CTRI/2022/03/041353 [Registered on: 24/03/2022] Trial Registered Prospectively
Last Modified On: 23/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessing Neurodevelopmental outcomes of neonates with low blood sugars 
Scientific Title of Study   To compare the neurodevelopmental outcomes of neonates with asymptomatic moderate to severe hypoglycemia vs symptomatic hypoglycemia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Thiruveedi Sruthi 
Designation  DNB neonatology resident 
Affiliation  Fernandez hospital 
Address  2nd floor,Department of neonatology, Fernandez hospital,Hyderguda, Hyderabad TELANGANA 500029 India

Hyderabad
TELANGANA
500029
India 
Phone  9490281522  
Fax    
Email  sruthi.thiruveedi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sai kiran 
Designation  Consultant neonatologist 
Affiliation  fernandez hospital 
Address  2nd floor,department of neonatology, Fernandez hospital 3-6-282, Basheerbaug road, AP housing board,Hyderguda,. Hyderabad TELANGANA 500029 India

Hyderabad
TELANGANA
500029
India 
Phone  9246847071  
Fax    
Email  drsai17@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sai kiran 
Designation  Consultant neonatologist 
Affiliation  fernandez hospital 
Address  2nd floor, department of neonatology,Fernandez hospital 3-6-282, Basheerbaug road, AP housing board, Hyderguda Hyderabad TELANGANA 500029 India

Hyderabad
TELANGANA
500029
India 
Phone  9246847071  
Fax    
Email  drsai17@gmail.com  
 
Source of Monetary or Material Support  
Fernandez hospital,hyderabad 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [none] 
 
Details of Secondary Sponsor  
Name  Address 
none  none 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Thiruveedi sruthi  Fernandez hospital, Hyderabad  2nd floor,department of neonatology,3-6-282, Hyderguda- Basheerbagh road, AP state housing board, Hyderguda, Hyderabad, Telengana 500029 Hyderabad TELANGANA
Hyderabad
TELANGANA 
9490281522

sruthi.thiruveedi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ehics committee,fernandez hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E15-E16||Other disorders of glucose regulation and pancreatic internal secretion, ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  Details Neonates of gestation > 32 weeks with hypoglycemia (both symptomatic and asymptomatic) on hand held glucometer reading will be considered  
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
(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
 
Total duration of NICU stay, at 6 months & 9-12 months corrected age 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hypoglycemia continues to be a common metabolic complication faced by newborns in developing countries. Both healthy and sick neonates can be affected by hypoglycemia during the first days of life. Factors placing neonates at higher risk for developing hypoglycemia are prematurity, being small or large for gestational age, perinatal stress or asphyxia, and being born to diabetic mothers.

Neonatal hypoglycemia is important because it is common and can cause brain damage. However, the blood glucose concentration and duration required to cause damage remains unclear. There was considerable variation among the centres, implying differences in decisions to intervene. The number of days on which moderate hypoglycemia occurred was strongly related to reduced mental and motor development scores at 18 months (corrected age), even after adjustment for a wide range of factors known to influence development. There are a few retrospective studies who had done assessment of neurodevelopmental outcome in children who presented with epilepsy beyond infancy secondary to neonatal hypoglycemia .There has been considerable debate over whether asymptomatic neonatal hypoglycaemia results in neurological damage.

The current study aims to compare the early adverse neurodevelopmental outcome  of neonates with asymptomatic hypoglycemia (ASH) Vs symptomatic hypoglycemia (SH) at 6 & 9-12 months of corrected gestation age. Developmental assessment will be done with Bayley Scales of Infant and Toddler Development Third Edition by single doctor certified in Bailey III. Composite adverse outcomes will be observed in both the groups (SH & ASH). Apart from the developmental assessment, we would like look into the other  co morbidities associated with neonatal hypoglycemia like aEEG abnormalities, presence of seizure disorder, tone abnormalities, vision impairment, hearing abnormalities and mortality in follow up. This is a prospective observational cohort study. Being a prospective study, it will overcome the selection bias.

 
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