| CTRI Number |
CTRI/2025/02/080726 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Differences in Brain Flow during Kangaroo care |
|
Scientific Title of Study
|
Comparision of effect of cerebral blood flow in preterm neonates during kmc given by father vs mother - a cross over randomized study |
| Trial Acronym |
none |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Somashekhar Nimbalkar |
| Designation |
Professor |
| Affiliation |
Bhaikaka University |
| Address |
Department of Neonatology
Pramukhswami Medical College
Karamsad
Anand GUJARAT 388325 India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Somashekhar Nimbalkar |
| Designation |
Professor |
| Affiliation |
Bhaikaka University |
| Address |
Department of Neonatology
Pramukhswami Medical College
Karamsad
Anand GUJARAT 388325 India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Somashekhar Nimbalkar |
| Designation |
Professor |
| Affiliation |
Bhaikaka University |
| Address |
Department of Neonatology
Pramukhswami Medical College
Karamsad
Anand GUJARAT 388325 India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology
Pramukhswami Medical College
Gokalnagar, Karamsad, Anand, Gujarat. Pin-388325 |
|
|
Primary Sponsor
|
| Name |
Bhaikaka University |
| Address |
Gokalnagar, Karamsad, Gujarat. Pin-388325 |
| 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 Somashekhar Nimbalkar |
Pramukhswami Medical College |
Room 1, NICU, First floor, Shree Krishna Hospital, Pramukhswami Medical College Anand GUJARAT |
9825087842
somu_somu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-2 Bhaikaka University, karamsad Anand Gujarat |
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 |
| Comparator Agent |
Kangaroo Care by Mother |
KMC is given by mother as normally done. KMC is given for one hour. Doppler flow is assessed in middle cerebral artery |
| Intervention |
Kangaroo Mother care by father |
KMC given to newborns as normally done. Duration of KMC is one hour. Here the provider is the father and we will assess the changes in cerebral blood flow |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
All Newborns eligible for KMC |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction rate of Resistive Index in MCA |
One hour of KMC. Day 1 of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pulsatility Index
Peak Systolic Velocity
End Diastolic Velocity |
One hour of KMC.
Day 1 of intervention. |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
03/03/2025 |
| 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="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
|
Skin-to-skin care, also known as
Kangaroo Mother Care (KMC), is a highly regarded and extensively studied
intervention for preterm neonates, involving the prone, upright positioning of
the neonate in direct skin-to-skin contact on the maternal chest. KMC is
associated with numerous health benefits for both the mother and the infant,
including reductions in morbidity and mortality, enhanced breastfeeding
success, increased weight gain, and improved mother-infant bonding [1,2].
Additionally, KMC has been shown to influence the development of neural
connections, contributing to long-term cognitive benefits such as brain
maturation, increased brain complexity, and better sleep organization. While
the majority of research on KMC has concentrated on its effects on cardio respiratory
parameters, the impact on cerebral hemodynamics remains less explored. Cerebral
blood flow (CBF) is a critical component of cerebral hemodynamics and has been
previously investigated in asphyxiated and preterm infants. However,
no study has yet been performed on the response of cerebral blood flow (CBF) in
preterm infants during KMC given by father and mother separately [3-6].
The assessment of CBF and
cerebral hemodynamics can be effectively conducted using pulsed Doppler
ultrasound techniques [7-9]. Spectral Doppler analysis and color flow mapping
are widely utilized in the evaluation of cerebral hemodynamic changes in premature
neonates, offering enhanced visualization of cerebral vessels and accurate
quantification of blood flow variations over time [8].
This study aims to elucidate the
differential effects of KMC provided by mothers and fathers on cerebral
hemodynamic indices, specifically targeting the middle cerebral artery,
alongside vital parameters in stable preterm infants.
|