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CTRI Number  CTRI/2025/10/096260 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Baby warmer clothes for stabilisation of neonatal body temerature. 
Scientific Title of Study   Baby Warmer Cloths With Adaptive Thermoregulation Property to Prevent Both Hypothermia and Hyperthermia in Twin Sharing Cot Versus Conventional Twin Sharing in Radiant Warmer: A Randomized Controlled Trial 
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. Dinesh Munian 
Designation  Associate Professor and SNCU in charge, Department of Paediatrics, Medical College, Kolkata 
Affiliation  Medical College,Kolkata 
Address  Department of Neonatology, SNCU-NICU Complex, Medical College, Kolkata, Eden Hospital, 88 College Street, Kolkata
Department of Neonatology, SNCU-NICU Complex, Medical College, Kolkata, Eden Hospital, 88 College Street, Kolkata
Kolkata
WEST BENGAL
700073
India 
Phone  9163288916  
Fax    
Email  dr.dineshmunian@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Arpan Saha 
Designation  2nd Year Academic Junior Resident, Department of Paediatrics  
Affiliation  Medical College,Kolkata  
Address  Department of Neonatology, SNCU-NICU Complex, Medical College, Kolkata, Eden Hospital, 88 College Street, Kolkata
Department of Neonatology, SNCU-NICU Complex, Medical College, Kolkata, Eden Hospital, 88 College Street, Kolkata
Kolkata
WEST BENGAL
700073
India 
Phone  9475453294  
Fax    
Email  arpansahamck183@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Arpan Saha 
Designation  2nd Year Academic Junior Resident, Department of Paediatrics  
Affiliation  Medical College,Kolkata  
Address  Department of Neonatology, SNCU-NICU Complex, Medical College, Kolkata, Eden Hospital, 88 College Street, Kolkata
Department of Neonatology, SNCU-NICU Complex, Medical College, Kolkata, Eden Hospital, 88 College Street, Kolkata
Kolkata
WEST BENGAL
700073
India 
Phone  9475453294  
Fax    
Email  arpansahamck183@gmail.com  
 
Source of Monetary or Material Support  
Medical College, Kolkata 
 
Primary Sponsor  
Name  DR ARPAN SAHA  
Address  88 College Street,Kolkata 700073 
Type of Sponsor  Other [Self funding ] 
 
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 Arpan Saha  Medical College, Kolkata  Department of Neonatology, SNCU-NICU Complex, Medical College, Kolkata
Kolkata
WEST BENGAL 
9475453294

arpansahamck183@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH MEDICAL COLLEGE KOLKATA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P809||Hypothermia of newborn, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Baby warmer clothes  Babies requiring thermal care and placed in a twin sharing cot will be wrapped with a special baby warmer clothes with adaptive thermoregulation property (each baby will be wrapped with separate clothes) along with routine care as per standard protocol. Temperature monitoring of each baby will be done as per study protocol and will be compared with babies in comparator group.  
Comparator Agent  Routine Care  Babies requiring thermal care and placed in a twin sharing cot will be provided routine care only as per standard protocol. Temperature monitoring of each baby will be done as per study protocol and will be compared with babies in intervention group. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  3.00 Day(s)
Gender  Both 
Details  Neonate born in this institution at gestational age between 32 to 37 completed weeks with birth weight more than 1200 grams requiring thermal care in a twin sharing cot but not requiring any ionotrope support or mechanical ventillation and whose parents provided informed written consent.  
 
ExclusionCriteria 
Details  Neonates with major congenital anomalies or suspected chromosomal disorder or requiring incubator care or phototherapy or surgical intervention during study period and neonates with hemodynamic instability or severe respiratory distress and any neonate who is previously enrolled in another interventional study and neonates with non consenting parents. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is number of incidence or episode of neonatal hypothermia or hyperthermia.   3days 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of SNCUstay,time to reach full enteral feeding,requirement and duration of respiratory support,occupancy of suspected or confirmed sepsis,neonatal mortality within 7 days  7 days 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   01/11/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Maintaining thermal stability is vital for neonatal survival, particularly among preterm and low birth-weight infants who are prone to both hypothermia and hyperthermia due to immature thermoregulation. In resource-limited sick newborn care units (SNCUs), it is common for twin neonates to share a radiant warmer because of equipment constraints. However, conventional radiant warmers often provide uneven and non-individualized heat distribution, resulting in temperature fluctuations and increased risk of thermal imbalance.

This randomized controlled trial aims to evaluate the effectiveness of baby warmer cloths with adaptive thermoregulation properties compared to conventional radiant warmer-based twin sharing in preventing thermal dysregulation. The study will be conducted in the SNCU of a tertiary care teaching hospital over one year. Twin neonates with gestational age between 32 to 37 weeks and birth weight more than 1200 grams will be randomized into two groups: the intervention group, where adaptive thermoregulating cloths (using phase change materials) will be applied separately for each baby  in a twin-sharing cot, and the control group will receive  standard radiant warmer care only.

The primary outcome is the incidence of hypothermia (less than 36.5 degree celcius) and hyperthermia (more than 37.5 degree celcius) during the first 72 hours of life. Secondary outcomes include mean temperature trends, changes in daily weight, percentage of heater output of radiant warmer ( overall energy consumption), care giver satisfection and occurrence of adverse thermal events such as dehydration, incidence of sepsis in each group. Data will be analyzed using appropriate statistical tests (SPSS 25)

It is expected that neonates in the adaptive cloth group will experience fewer episodes of thermal instability, improved comfort, and reduced dependence on mechanical warming devices. The findings could support the integration of adaptive thermoregulating baby warmer cloths as a safe, sustainable, and cost-effective solution for neonatal thermal management, especially in twin-sharing scenarios and resource-limited healthcare settings.
 
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