| 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
|
|
|
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
|
|
|
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
|
|
|
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. |