| CTRI Number |
CTRI/2024/06/069676 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [prospective observational study with analytical design] |
| Study Design |
Other |
|
Public Title of Study
|
Benefits of Kangaroo mother care in infants requiring respiratory support |
|
Scientific Title of Study
|
Effect of kangaroo mother care on cerebral hemodynamics of very preterm neonates on non-invasive respiratory support- A prospective 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 |
Dr Komaragiri Sai Sreevani |
| Designation |
DrNB neonatology resident |
| Affiliation |
Fernandez Hospital, Hyderabad |
| Address |
Fernandez Hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana.
Hyderabad TELANGANA 500034 India |
| Phone |
9010439439 |
| Fax |
|
| Email |
sreevanikomaragiri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tejo Pratap Oleti |
| Designation |
HOD, Neonatology |
| Affiliation |
Fernandez Hospital |
| Address |
Fernandez Hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana.
Hyderabad TELANGANA 500034 India |
| Phone |
9989372490 |
| Fax |
|
| Email |
tejopratap@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tejo Pratap Oleti |
| Designation |
HOD, Neonatology |
| Affiliation |
Fernandez Hospital |
| Address |
Fernandez Hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana.
Hyderabad TELANGANA 500034 India |
| Phone |
9989372490 |
| Fax |
|
| Email |
tejopratap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fernandez hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana - 500034. |
|
|
Primary Sponsor
|
| Name |
Fernandez Hospital |
| Address |
Fernandez Hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana - 500034 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Komaragiri Sai Sreevani |
Fernandez hospital |
Neonatal Intensive Care Unit, Department of Neonatology, Room no 302, 3rd floor,Fernandez hospital, No.8-2-698, Rd number 12, bhola nagar, banjara hills, Hyderabad, 500034 Hyderabad TELANGANA |
9010439439
sreevanikomaragiri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board , Fernandez Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post-KMC group |
The eligible neonates will be assessed for cerebral blood flow dynamics with a neurosonogram after initiating the skin to skin contact of mother-infant dyad as a part of KMC. The assessment will be done within 2 hrs after ensuring that the KMC duration is more than equal to 1 hour. |
| Comparator Agent |
Pre-KMC group |
The eligible neonates will be assessed for cerebral blood flow dynamics with a neurosonogram before initiating the skin to skin contact of mother-infant dyad as a part of KMC. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
All Very preterm neonates born before 30 weeks of gestation, requiring non-invasive respiratory support and hemodynamically stable |
|
| ExclusionCriteria |
| Details |
Neonates born with major congenital anomaly, pre-existing neurological morbidities and hydrops |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the changes in cerebral hemodynamics in very preterm neonates on non-invasive respiratory support during KMC using transcranial doppler ultrasonography in the first 3 days of its initiation. |
From the starting of the initiation of KMC to the 2 consecutive days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the changes in vital physiological parameters like heart rate, saturations and mean blood pressure before and after KMC during the first 3 days of initiation.
2) To analyze the regional cerebral oxygenation changes as measured by Near Infrared Spectroscopy (NIRS) during the first 3 days of its initiation. |
From the starting of the initiation of KMC to the 2 consecutive days |
|
|
Target Sample Size
|
Total Sample Size="53" Sample Size from India="53"
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)
|
11/07/2024 |
| 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="1" Months="6" 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 - NO
|
|
Brief Summary
|
In neonates who were born before term gestation especially before 34 weeks it is believed to cause an interruption in their smooth and integrated neurobehavioral development. Preterm neonates are more susceptible to neuronal injury because of their physiological immaturities in cerebral vasculature and ineffective cerebral autoregulation which can cause marked fluctuations in cerebral blood flow. This results in adverse cerebrovascular events which can have longterm effects on neurodevelopment in the form of cognitive, motor and behavioral abnormalities. The advances in perinatal and neonatal medicine over the past two decades improved the survival of extreme and very preterm neonates which also resulted in increased neuro-morbidity among the survivors. Hence neuroprotective strategies should be made an integral part of neonatal care thereby promoting better longterm neurodevelopmental outcomes. Kangaroo Mother Care (KMC) is a proven and effective method of care for preterm infants which means skin-to-skin contact (SSC) between the neonate and the parent especially the mother. Preterm birth results in an increase in number of days of NICU stay and separation of newborn and the mother. This SSC between mother and the baby promotes a multi-sensory stimulation for their development. As only few studies have shown the beneficial effects of KMC on cerebral hemodynamics in very preterm neonates who are given SSC as early as possible even on non-invasive respiratory support we wish to analyze the changes to make KMC an integral part of neuroprotective care among the neonates. Most of the studies done on stable preterm neonates were around the gestational age of 30-34 weeks of gestation and less data on neonates between 26-30 weeks of gestation who require more days of respiratory support which might effect their neurodevelopmental outcomes and these are the newborns who are separated from their parents for a longer time and hence this study might help in giving earlier and aggressive KMC as part of developmentally supportive care in these newborns. The studies were done in a single session and the consistency of the results has not been studied well. In this study we wanted to study for at least a period of 3 days to know the efficacy in a broader way. |