| 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
|
|
|
Primary Sponsor
|
| Name |
DR ARPAN SAHA |
| Address |
88 College Street,Kolkata 700073 |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 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
|
|
|
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. |