| CTRI Number |
CTRI/2024/09/074128 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Effectieness of early initiation of KMC in Neonates weighing less than 1800 grams in a Neonatal Intensive Care Unit odisha. |
|
Scientific Title of Study
|
Effect of early Kangaroo Mothercare in Neonates weighing less than 1800 gram in Neonatal Intensive Care set up,Odisha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Purnima Sahoo |
| Designation |
Associate Professor |
| Affiliation |
KINS,KIIT Deemed To Be University |
| Address |
KIMS,CAMPUS-5
KIIT Deemed To Be University
Patia,Bhubaneswar
Odisha
Neonatal Intensive Care Unit
KMC Unit
Kalinga Institute Of Nursing Sciences
KIMS,CAMPUS-5
KIIT Deemed To Be University
Patia,Bhubaneswar
Odisha,751024
Khordha
ORISSA
751024
India |
| Phone |
9124475001 |
| Fax |
|
| Email |
punisahoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Purnima Sahoo |
| Designation |
Associate Professor |
| Affiliation |
KINS,KIIT Deemed To Be University |
| Address |
KIMS,CAMPUS-5
KIIT Deemed To Be University
Patia,Bhubaneswar
Odisha
Neonatal Intensive Care Unit
KMC Unit
KIMS,CAMPUS-5
KIIT Deemed To Be University
Patia,Bhubaneswar
Odisha,751024
Khordha
ORISSA
751024
India |
| Phone |
9124475001 |
| Fax |
|
| Email |
punisahoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Santosh Kumar Panda |
| Designation |
Associate Professor,Dept. of Neonatology |
| Affiliation |
KIMS,KIIT Deemed To Be University |
| Address |
KIMS,CAMPUS -5
KIIT Deemed To Be University
Patia,Bhubaneswar
Odisha,751024
Neonatal Intensive Care Unit
KMC Unit
KIMS,CAMPUS -5
KIIT Deemed To Be University
Patia,Bhubaneswar
Odisha,751024
Khordha
ORISSA
751024
India |
| Phone |
9778182963 |
| Fax |
|
| Email |
santosh.panda@kims.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PURNIMA SAHOO |
| Address |
KIMS,KIIT DU,CAMPUS-5, PATIA,BHUBANESWAR
ODISHA. POSTAL CODE: 751024, INDIA. |
| 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 Santosh Ku Panda |
Pradyumna Bal Memorial Hospital, Bhubaneswer |
PBMH,KIMS,KIIT CAMPUS-5,PATIA,BHUBANESWAR
751024
Khordha
ORISSA |
9124475001
punisahoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS,KIIT DEEMED TO BE UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed Kangaroo mother care |
To compare the neonatal morbidity and mortality in neonates initiates early KMC with in 7days of life vs after 7 days of extrauterine life. |
| Intervention |
Early Kangaroo Mother Care |
We defined KMC as skin-to-skin contact in the kangaroo position. This involved placing the naked neonate, (except for a hat and diaper) in a prone position next to the caregivers chest, adopting a frog-leg posture with the head turned sideways. A bed sheet was utilized to secure the neonate in the KMC position, covering both the baby and the mother for ease access baby. The researcher encouraged the KMC provider to initiate immediate start of KMC after baby admitted to NICU and to maintain as close to continuous skin-to-skin contact as possible, with the goal of achieving extended sessions lasting more than 8 hours. All other treatments were to be continued concurrently with KMC (All types of respiratory support except ventilator, gastric tube feeding, intravenous fluid via peripheral venous cannula etc). If participants meet the Clinical stopping criteria for KMC then participant can temporarily withdraw from the intervention. The pre-specified criteria to stop KMC included: severe instability, including need for ventilator; apnea needing resuscitation; widespread rash on neonate or KMC provider; severe abdominal distension; omphalitis; phototherapy; blood transfusion; seizures, and KMC UVC or unavailable to provide continuous KMC. Criteria for re-starting KMC were also pre-specified. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
a. Admitted in NICU with weight ≤1800gm.
b. Single tone pregnancy.
|
|
| ExclusionCriteria |
| Details |
a. Presence of major congenital anomalies.
b. Baby weight less than 1000gram.
c. Multiple pregnancy
d. Persistent need for inotrope/s for the first seven days of life.
e. Lack of family consent to participate.
f. Mother admitted in ICU and lack of availability of family member
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Morbidity and Mortality |
2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cardio-respiratorystability
prevalence of hypothermia
exclusively breastfeeding
daily weight gain
clinically suspected infection |
2 years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - On request email to punisahoo@gmail.com.
- For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Prematurity is the primary cause of death for children under five worldwide. There are significant disparities in survival rates between countries. Kangaroo Mother Care (KMC) is one of the most important live saving interventions and standards of care for the LBW infants under all circumstances.The best approach to effectively satisfy a kangaroo mother’s basic needs is to provide warmth, nutrition, immunity to illness, multi-modal stimulation, safety, and love. More than 80% of deaths involve LBW new-borns and KMC is the answer to all of this. KMC not only regulates body temperature but also supports numerous physiological processes such as oxygenation, apnea reduction, hypoglycemia reduction, infection reduction, and nosocomial sepsis reduction . The purpose of this study is to evaluate the use of Early Kangaroo Mother Care, or E-KMC, for LBW babies in neonatal intensive care settings through a thorough evaluation of the body. Further, to examine the advantages of preterm outcomes such as late onset sepsis (also known as clinical or blood culture positive sepsis), breast milk availability, feeding intolerance, time to full feeds, NEC, TPNduration, extrauterine growth retardation, bronchopulmonary dysplasia, osteopenia of prematurity, IVH,NICU stay, discharge weight, and NICU mortality. This project aims to offer important insights into the best care of preterm and LBW infants in NICU settings by putting evidence-based approaches into practice. The results could enhance infant outcomes, influence healthcare legislation, and guide clinical practice standards and also influences on the discharge of home KMC following hospital discharge. |