| CTRI Number |
CTRI/2024/04/066212 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Tools to predict early mortality in neonates with moderate to severe birth asphyxia an observational study |
|
Scientific Title of Study
|
Early predictors of Mortality in babies with birth asphyxia having moderate or severe encephalopathy - An Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaik Mohammed Munthakheem |
| Designation |
Senior Resident |
| Affiliation |
Government medical college |
| Address |
B6-304,my world apartments, opposite airport,chikalthana,Aurangabad
Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9620107364 |
| Fax |
|
| Email |
munthakheem93@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shaik Mohammed Munthakheem |
| Designation |
Senior Resident |
| Affiliation |
Government medical college |
| Address |
B6-304,my world apartments, opposite airport,chikalthana,Aurangabad
Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9620107364 |
| Fax |
|
| Email |
munthakheem93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shaik Mohammed Munthakheem |
| Designation |
Senior Resident |
| Affiliation |
Government medical college |
| Address |
B6-304,my world apartments, opposite airport,chikalthana,Aurangabad
Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9620107364 |
| Fax |
|
| Email |
munthakheem93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college |
|
|
Primary Sponsor
|
| Name |
Shaik Mohammed Munthakheem |
| Address |
B6-304,my world apartments, opposite airport,chikalthana,Aurangabad
Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra 431001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shaik Mohammed Munthakheem |
Government medical college |
Department of Neonatology, 2nd floor, Surgical building, government medical college (GHATI) Aurangabad Aurangabad MAHARASHTRA |
9620107364
munthakheem93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Govt Medical college aurangabad ( IEC-GMCA ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P916||Hypoxic ischemic encephalopathy [HIE], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
All inborn babies more than 37 weeks with moderated to severe encephalopathy developed within first 24 hours after birth as per NICHD criteria |
|
| ExclusionCriteria |
| Details |
Neonates born with major congenital malformations, chromosomal abnormalities, or any metabolic disorders.Preterms less than 37 weeks |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of the nSOFA for predicting in-hospital mortality (sensitivity, specificity) following hypoxic–ischemic encephalopathy |
Death or discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
No of days of hospital stay
No of ventilation days (Invasive and Non invasive)
Need of AED’s
aEEG abnormalities
MRI abnormalities
Death / discharge. |
Death or discharge |
|
|
Target Sample Size
|
Total Sample Size="370" Sample Size from India="370"
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)
|
29/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The essential component to neonatal adaptation after birth is the initiation of adequate respiratory effort. Approximately 10–15% of newborns require support for respiratory transition at birth, 3% require positive pressure ventilation by mask, 2% intubation, and only <1% cardiopulmonary resuscitation with chest compressions or epinephrine to establish cardiorespiratory function [1,2]. The major cause for delivery room cardiopulmonary resuscitation is birth asphyxia, a condition of insufficient oxygen supply to vital organs that results in hypoxia, hypercarbia, and metabolic acidosis and, if prolonged, may progress to multiorgan failure, including the developing brain, which is then referred to as hypoxic ischemic encephalopathy [3, 4]. The neonatal modification of the SOFA (nSOFA) was proposed to address the need for a consensus definition of neonatal sepsis in 2020 [13]. nSOFA uses three objective and broadly available clinical parameters to quantify organ dysfunction: respiratory, cardiovascular, and hematological scores (total scores range from 0 to 15). It was previously used for predicting mortality and severe morbidity in preterm infants [14], preterm infants with late onset sepsis [15], respiratory distress syndrome (RDS) [16], and neonates with proven sepsis [13,17]. Thus, the score was already shown to be predictive independent of the cause of organ dysfunction in the first 24 and 72 h.The aim of the present study was to evaluate the accuracy of the nSOFA for predicting in-hospital mortality (sensitivity, specificity) following moderate to severe hypoxic–ischemic encephalopathy |