| CTRI Number |
CTRI/2021/05/033670 [Registered on: 18/05/2021] Trial Registered Prospectively |
| Last Modified On: |
23/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Measures to reduce hypothermia among neonates |
|
Scientific Title of Study
|
Quality improvement measures in reducing hypothermia among at-risk neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soham Kulkarni |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college |
| Address |
Department of Paediatrics,
Kasturba medical college
Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sohamk910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Purkayastha |
| Designation |
Professor |
| Affiliation |
Kasturba medical college |
| Address |
Department of Paediatrics,
Kasturba medical college
Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
jayashreepurkayastha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soham Kulkarni |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college |
| Address |
Department of Paediatrics,
Kasturba medical college
Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sohamk910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics,
Kasturba Medical college and Kasturba Hospital,
Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Soham Kulkarni |
| Address |
Department of Paediatrics,
Kasturba medical college,
Manipal |
| 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 Soham Kulkarni |
Kasturba medical college |
NICU, Department of Paediatrics,
First floor, Women and children’s block,
Kasturba medical college and Kasturba Hospital, Madhav nagar, Manipal
Udupi
KARNATAKA |
7588255605
sohamk910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P808||Other hypothermia of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypothermia prevention bundle |
Quality improvement bundle will include use of plastic wraps, exothermic blankets, caps, socks and gloves wherever applicable and any other measures based on phase I data. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
1. All neonates delivered at Kasturba hospital, Manipal with gestational age less than 32 weeks or birth weight less than 1500 g and admitted to NICU
2. Neonates transported to Operating Rooms for surgical intervention
3. Neonates requiring intra hospital transport for imaging studies. |
|
| ExclusionCriteria |
| Details |
1. Neonates less than 24 weeks of gestation
2. Neonates less than 500 g birth weight
3. Neonates with major congenital malformations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of improvement in thermoregulation after QI. |
Phase I- May 2021-September 2021
Phase II- October 2021- February 2022
Phase III- March 2022- August 2022 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in percentage of mortality and morbidity associated with hypothermia. |
Phase I- May 2021-September 2021
Phase II- October 2021- February 2022
Phase III- March 2022- August 2022 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "139"
Final Enrollment numbers achieved (India)="139" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
25/05/2021 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Phase I-
Axillary temperature using digital thermometer of 1. All VLBW babies delivered at Kasturba hospital will be measured after resuscitation and at admission to NICU. 2. All babies going for surgery to OT before leaving and at arrival to NICU 3. All babies going for investigations (CT,MRI) before leaving and at arrival to NICU. Incidence of hypothermia will be noted.
Phase II-
Hypothermia prevention team (myself along with nursing staff and neonatology staff representatives ) will optimise the NICU policy for neonatal transport with inputs from OBGY, Anaesthesia and radiology staff. 1. Knowledge of health care providers pre quality improvement will be tested by questionnaire 2. Quality improvement bundle will be developed based on phase I data analysis. 3. Quality improvement bundle will include use of plastic wraps, exothermic blankets, caps, socks and gloves wherever applicable and any other measures based on phase I data. 4. Quality improvement bundle and feasibility of thermoregulatory equipment will be based on neonatal needs
Phase III-
1. Knowledge of health care providers post quality improvement will be tested by questionnaire 2. Axillary temperatures will be measured by digital thermometers after implementation of new initiatives
The results will then be compared with pre quality improvement values. |