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CTRI Number  CTRI/2024/10/074821 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The current study is based on the effect of reversed kangaroo mother care on level of pain and physiological parameters of preterm neonates and mothers anxiety during screening of retinopathy of prematurity. 
Scientific Title of Study   Effectiveness of Reversed Kangaroo Mother Care Positioning on Level of Pain, Physiological Parameters among Preterm infants, and Mothers anxiety during the Screening of Retinopathy of Prematurity in selected tertiary care hospital-A Randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha Praharaj 
Designation  Assistant Professor 
Affiliation  Ms.  
Address  SUM Nursing College Campus 2 ghatikia Bhubneswar Khordha
SUM Nursing College Campus 2 ghatikia Bhubneswar Khordha
Khordha
ORISSA
751003
India 
Phone  9937463998  
Fax    
Email  manishapraharaj21486@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manisha Praharaj 
Designation  Assistant Professor 
Affiliation  Ms.  
Address  SUM Nursing College Campus 2 ghatikia Bhubneswar Khordha
SUM Nursing College Campus 2 ghatikia Bhubneswar Khordha
Khordha
ORISSA
751003
India 
Phone  9937463998  
Fax    
Email  manishapraharaj21486@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manisha Praharaj 
Designation  Assistant Professor 
Affiliation  SOA deemed to be university 
Address  SUM Nursing College Campus 2 ghatikia Bhubneswar Khordha
SUM Nursing College Campus 2 ghatikia Bhubneswar Khordha
Khordha
ORISSA
751003
India 
Phone  9937463998  
Fax    
Email  manishapraharaj21486@gmail.com  
 
Source of Monetary or Material Support  
Siksha O Anusandhan University SUM Nursing College Campus 2 Ghatikia Bhubneswar Khordha Odisha India 751003 
 
Primary Sponsor  
Name  Siksha O Anusandhan University 
Address  SUM Nursing college Campus-2 Ghatikia Bhubneswar 751003 
Type of Sponsor  Research institution 
 
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 Pravati Tripathy  IMS & SUM Hospital  Ward No.13 Neonatal Intensive Care Unit Department of Neonatology IMS & SUM Hospital
Khordha
ORISSA 		 9937463998

dean.snc@soa.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee institute of medical sciences (IMS) and SUM hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z139||Encounter for screening, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Conventional Group Procedure The conventional method described is the standard hospital protocol for performing ROP screening. In this group, the baby is managed entirely by medical staff, without the mother’s involvement. Here’s how the procedure works: 1. Neonate’s Positioning: The preterm neonate will be placed supine (on their back) on a radiant warmer. Radiant warmers are used in hospitals to keep new-borns at a stable body temperature. The baby will be swaddled tightly in a blanket, providing some degree of restraint to prevent excessive movement during the screening. 2. Manual Restraint: An assistant (typically a nurse or another medical staff member) will be present to hold the neonate’s extremities and head during the procedure. The assistant will carefully restrain the baby’s arms, legs, and head, ensuring that the infant remains still for the duration of the ROP examination. 
Intervention  reversed Kangaroo Mother Care  1. Mother’s Preparation: The mother will be dressed in a Kangaroo Mother Care (KMC) gown. This special gown is designed to facilitate skin-to-skin contact between the mother and the baby. The baby will be positioned in a supine position (lying on their back) over the mothers chest. The baby’s back will be in direct contact with the mothers chest, promoting warmth and closeness. 2. Securing the Baby: Both the mother and baby will be wrapped together using a KMC cloth, ensuring that the baby remains snug and secure during the procedure. The mother will be instructed to hold the baby in a specific manner: One of her hands will be placed over the baby’s chest. This hand will also be used to restrain the baby’s arms, preventing them from moving too much during the examination. The other hand will be used to gently restrain the baby’s legs. This method of restraint ensures that the baby remains in a calm and secure position, with their body properly aligned and eyes facing forward toward the examiner. This positioning is crucial for a successful eye examination. 3. Lying on the Examination Couch: After the formal training, the mother will be asked to lie supine (on her back) on the examination couch, maintaining the R-KMC position. Once the mother is in place, the baby will remain in the same R-KMC position on the mother’s chest. This helps reduce stress for the infant by maintaining the comfort of skin-to-skin contact, warmth, and security during the screening. 
 
Inclusion Criteria  
Age From  7.00 Month(s)
Age To  8.00 Month(s)
Gender  Both 
Details  Preterm birth with a gestational age less than and equal to 34 weeks
Weight less than 2000g.
No prior history of fundus screening.
 
 
ExclusionCriteria 
Details  Preterm babies with critical conditions such as severe respiratory distress, central nervous system infection, sepsis, etc.
Other diseases, such as congenital heart malformation, pulmonary insufficiency, etc.
Babies who received NSAID, sedative, or antiepileptic drugs within 24 hours before screening.
Mothers who are in ICU, mentally unstable, unconscious or who cannot hold and sit on KMC chair. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain level  3 times 
 
Secondary Outcome  
Outcome  TimePoints 
neonates physiological Parameters maternal Stress satisfaction  one time 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/11/2024 
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   The study proposal has been submitted to the university and is now registered under its records. It has also been reviewed and approved by the Institutional Ethics Committee, and a reference number has been issued. A data collection tool has been developed to gather participant information, which has been sent to experts for validation and reliability testing. A pretest will be conducted once the reliability of the tool is confirmed. The reverse Kangaroo Mother Care (KMC) intervention has been prepared and submitted to experts for validation. Based on the feedback received, minor modifications were made to the intervention as suggested by the experts. the sample will be enrolled based on the rendomizat5ion process. Following the completion of a pilot study, the main research will be conducted by enrolling mothers and their preterm infants to assess the pain levels and maternal satisfaction with the revised KMC procedures during the retinopathy of prematurity. 
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