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CTRI Number  CTRI/2024/09/074097 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 17/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Kangaroo Mother Care on Preterm babies 
Scientific Title of Study   Effectiveness of Kangaroo Mother Care on Preterm babies in Tertiary care hospital: A Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC/RMCH/99/2024/APR  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr CHINNADURAI M 
Designation  Junior Resident 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,BAREILLY 
Address  Room No.3008,Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  7397246211  
Fax    
Email  mchinnadurai096@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ROSHAN LAL SHARMA 
Designation  PROFESSOR  
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,BAREILLY 
Address  Room No.3004,Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9418150377  
Fax    
Email  drroshan16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr CHINNADURAI M 
Designation  Junior Resident 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,BAREILLY 
Address  Room No.3008,Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  7397246211  
Fax    
Email  mchinnadurai096@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly-243006, Uttar pradesh, India. 
 
Primary Sponsor  
Name  Dr CHINNADURAI M 
Address  Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly-243006, Uttar Pradesh, India. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR CHINNADURAI M  Rohilkhand Medical College and Hospital  Room No.3004, Department of Paediatrics, 2 nd floor, Pilibhit Bypass Road, Pawan Vihar, Bareilly, Uttar pradesh-243006
Bareilly
UTTAR PRADESH 
7397246211

mchinnadurai096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,RMCH,BAREILLY,U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group provided with Kangaroo Mother Care (Interventional group)  KMC group -Kangaroo mother care with normal routine NICU care. KMC in KMC group neonate provided for maximum possible duration in a day till mother will be comfortable [minimum 4 hours per day]. Drug Not applicable, No drug therapy.  
Comparator Agent  Group provided with Routine care (Control group)  Routine new born care. Drug Not applicable, No drug therapy.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  9.00 Month(s)
Gender  Both 
Details  All Hemodynamically stable preterm neonates admitted in NICU and Postnatal ward after delivery at Rohilkhand Medical College and Hospital 
 
ExclusionCriteria 
Details  1.Neonates with major congenital malformation.
2.Perinatal Asphyxia [HIE II/HIE III].
3.Intraventricular Hemorrhage greater than 2 grade.
4.Neonates requiring any surgical intervention.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Average weight gain
2.Frequency of feed intolerance in terms of feed regurgitation and abdominal distention
3.Presence of necrotizing enterocolitis
4.Duration of Hospital stay
5.Vital parameters (Heart Rate, Respiratory Rate, SpO2)


 
At the time of discharge, Patients anthropometric indices like weight, Length and head circumference will be recorded. Then
patients will be followed up in paediatric OPD at 6 weeks, 10 weeks and at 14 weeks of age and at 6 months of age. The weight, length and head circumference will be recorded with each follow up. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of Hospital stay  At the time of discharge, Patients anthropometric indices like weight, Length & head circumference will be recorded. Then patients will be followed up in paediatric OPD at 6 weeks, 10 weeks & at 14 weeks of age & at 6 months of age. The weight, length & head circumference will be recorded with each follow up. 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   15/10/2024 
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="1"
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 - NO
Brief Summary   After taking clearance from Institutional Ethics Committee, Rohilkhand Medical College and Hospital, Bareilly, the study will be conducted.
 ï‚· Written informed consent will be taken from parents/guardians of all the patients participating in the study in a language they can understand. Anonymity will be proposed as optional and confidentiality will be maintained. 
 ï‚· All babies fulfilling inclusion criteria randomized in two groups: 
 Group 1: KMC group -Kangaroo mother care with normal routine NICU care
 Group 2: Control group –Routine new born care 
For randomization, we use computer generated random numbers.
Blinding: The sealed envelope will be opened by the staff on duty under the supervision of study doctor. The interventions which will be written on the slip will be carried out by the resident doctors and staff on duty not involved in the study. 
 INTERVENTION-Residents doctors and staff involved in KMC of neonates trained for Kangaroo mother care by showing live demonstration of KMC by primary investigators and showing a video produced by World Health Organization in collaboration with AIIMS, New Delhi. Randomly allocated intervention group neonates with KMC during KMC position by trained staff and resident doctors according to the treatment orders and protocols specified in AIIMS NICU protocol. KMC in KMC group neonate provided for maximum possible duration in a day till mother will be comfortable [minimum 4 hours per day]. 
ï‚· A comfortable environment will be provided for mothers by wearing hospital clothes after washing their hands, keeping the opening in front, and then lying on the bed and head elevated to a 45° angle to provide a comfortable reclining position. In order to emphasize skin-to-skin contact, the newborn was then placed on the mother’s bare chest while only wearing a diaper, socks, cap, and mittens. In order to maintain the newborn’s open airway and promote mother-child eye contact, a soft blanket was placed around the mother and child. To help with KMC, the mother’s hands were placed over the blankets and gently pressed against the neonate’s back to stabilize them. 
ï‚· Determine a time that’s suitable for the mother and the baby when the child is ready for KMC. The early sessions are crucial and require for a lot of interactions. Explain her how to adhere to the KMC process patiently, gently, and with compassion. Invite her to bring her husband, mother-in-law, or any other family member. It contributes to the family’s positive mental state and guarantees the mother’s support. 
 Short: 4 hours a day. 
Extended: five to eight hours per day.
Length: nine to twelve hours every day.
Continuous: More than twelve hours per day recorded for at least two days consecutively or more before being discharged. 
ï‚· KMC is linked to a lower incidence of serious illnesses in neonates, such as pneumonia. KMC has been found to be more effective than incubator care for stable newborns in the majority of studies. This is because KMC encourages greater maternal and family involvement in care, provides adequate thermal care, reduces nosocomial infections, improves exclusive breastfeeding and weight gain, and is less expensive than incubator care. The baby’s five senses are fully satisfied by KMC. The baby listens to her mother voice and has skin-to-skin contact (touch) to sense the warmth of her mother, listens to her voice and heartbeat (hearing), sucks breast milk (taste) has eye contact with her (vision) and smells her odor (olfaction) 
ï‚· Following that, a pulse oximetry probe will be attached to the neonate’s right wrist prior to feeding in order to measure vital signs like heart rate and oxygen saturation. For an entire one minute, the respiratory rate was recorded. ï‚· Finally after 30 minutes of feed administration and KMC neonates’ physiological parameters and feeding intolerance parameters were assessed including any feed regurgitation and abdominal distension. KMC was continued for maximum possible duration. Feed intolerance and NEC grading was defined based on AIIMS NICU protocol.
 
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