| CTRI Number |
CTRI/2018/05/014170 [Registered on: 29/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
Using SNAPPE II scoring system in the babies admitted in NICU for predicting mortality and morbidity - An observational study |
|
Scientific Title of Study
|
Score for neonatal acute physiology with perinatal extension –II (SNAPPE –II) in predicting mortality and morbidity in NICU – An observation study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok V Badakali |
| Designation |
Professor |
| Affiliation |
S.N.Medical college,Bagalkot |
| Address |
Dept of Pediatrics,
S.N.Medical college,Bagalkot.
Bagalkot
KARNATAKA
587102
India |
| Phone |
9880227403 |
| Fax |
|
| Email |
ashok_diya@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhunandan K |
| Designation |
Post graduate/ Junior resident |
| Affiliation |
S.N.Medical college, Bagalkot. |
| Address |
Dept of Pediatrics,
S.N.Medical college, Bagalkot.
Bagalkot
KARNATAKA
587102
India |
| Phone |
9844554001 |
| Fax |
|
| Email |
madhunandangowda7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhunandan K |
| Designation |
Post graduate/ Junior resident |
| Affiliation |
S.N.Medical college, Bagalkot. |
| Address |
Dept of Pediatrics,
S.N.Medical college, Bagalkot.
Bagalkot
KARNATAKA
587102
India |
| Phone |
9844554001 |
| Fax |
|
| Email |
madhunandangowda7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ashok V Badakali |
| Address |
Department of pediatrics
SNMC and HSK Hospital Bagalkot- 587102 |
| Type of Sponsor |
Private medical college |
|
|
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 ASHOK V BADAKALI |
Neonatal intensive care unit |
Department of pediatrics
SNMC AND HSK hospital
Bagalkot - 587102
Bagalkot
KARNATAKA |
9880227403
ashok_diya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC - INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
sick newborn, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
Neonates within 48 hours of life admitted to NICU are included. |
|
| ExclusionCriteria |
| Details |
1.NEONATES WITH CONGENITAL MALFORMATIONS INCOMPATIBLE WITH LIFE
2.OUTBORN NEONATES WHERE APGAR SCORES ARE NOT KNOWN |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neonatal mortality and morbidity in terms of hospital stay can be found using physiological factors (mean blood pressure, temperature, uine output, presence of multiple seizures) laboratory parameters (arterial blood gas analysis for pH and pO2) and perinatal factors (birth weight, gestational age, apgar score at 5 minutes) |
Neonatal mortality and morbidity in terms of hospital stay can be found using physiological factors (mean blood pressure, temperature, uine output, presence of multiple seizures) laboratory parameters (arterial blood gas analysis for pH and pO2) and perinatal factors (birth weight, gestational age, apgar score at 5 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neonatal mortality and morbidity in terms of hospital stay can be found using physiological factors (mean blood pressure, temperature, uine output, presence of multiple seizures) laboratory parameters (arterial blood gas analysis for pH and pO2) and perinatal factors (birth weight, gestational age, apgar score at 5 minutes) |
Neonatal mortality and morbidity in terms of hospital stay can be found using physiological factors (mean blood pressure, temperature,uine output, presence of multiple seizures) laboratory parameters (arterial blood gas analysis for pH and pO2) and perinatal factors (birth weight, gestational age,apgar score at 5 minutes) |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
11/11/2016 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Severity of measurements in NICUs (neonatal intensive care units) has traditionally employed birth weight and APGAR scores, as two main factors, for mortality prediction. The relationship between mortality rate and the factors have, however, been insufficiently precise in quality assessment of neonatal intensive care settings. In addition, rapid progress of neonatal care has made the relationship between these factors and mortality rate unstable . Survival of the newborns who are admitted to the NICUs do not depend exclusively on birth weight and gestational age, but also on other perinatal factors and physiological conditions of the individual infants, in particular severity of their diseases . SNAPPE II includes mean blood pressure, temperature, PO 2 /FiO 2 , pH, multiple seizures, urine output, APGAR score, birth weight and small for gestational age. These scores give weightage for certain parameters to predict outcome for a newborn. Hence the present study aims to analyze the influence of physiologic factors (mean blood pressure, temperature, urine output, presence of multiple seizures) laboratory parameters (arterial blood gas analysis for pH and PO 2 ) and perinatal factors (eg., birth weight, gestational age, APGAR score at 5 minutes) on the mortality in neonates. Statistical analysis: Data will be analyzed using SPSS version 11, chisquare test for qualitative data and students t test for quantitative data, ROC curve analysis will be done to findout criterion value. P value <0.05 will be considered significant. outcome : Neonatal mortality and morbidity in terms of hospital stay can be found out using physiologic factor , lab parameters and perinatal factors |