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CTRI Number  CTRI/2024/03/063749 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare two different methods of reducing water loss through skin in immature infants in first week of life 
Scientific Title of Study   A randomized comparative trial of two different strategies to reduce insensible water loss in preterm infants of less than 32 weeks gestation in the first postnatal week  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreetama Das 
Designation  Senior Resident 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Department of Neonatology, Division-Neonatal Intensive Care Unit, Room No.1,244 AJC Bose Road, PS-Bhowanipore,West Bengal 700020 INDIA

Kolkata
WEST BENGAL
700020
India 
Phone  9903978005  
Fax    
Email  sreetama.das6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sreetama Das 
Designation  Senior Resident 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Department of Neonatology, Division-Neonatal Intensive Care Unit, Room No.1,244 AJC Bose Road, PS-Bhowanipore,West Bengal 700020 INDIA

Kolkata
WEST BENGAL
700020
India 
Phone  9903978005  
Fax    
Email  sreetama.das6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sreetama Das 
Designation  Senior Resident 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Department of Neonatology, Division-Neonatal Intensive Care Unit, Room No.1,244 AJC Bose Road, PS-Bhowanipore,West Bengal 700020 INDIA

Kolkata
WEST BENGAL
700020
India 
Phone  9903978005  
Fax    
Email  sreetama.das6@gmail.com  
 
Source of Monetary or Material Support  
Institute of Post Graduate Medical Education and Research 
 
Primary Sponsor  
Name  Institute of Post Graduate Medical Education and Research 
Address  244 AJC BOSE ROAD,BHOWANIPORE,KOLKATA 700020 
Type of Sponsor  Government medical college 
 
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 Sreetama Das  Institute of Post Graduate Medical Education and Research  Room No. 1 Department of Neonatology, Division-Neonatal Intensive Care Unit
Kolkata
WEST BENGAL 		 9903978005

sreetama.das6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Research Advisory Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control arm  Babies will be nursed in an open radiant care unit. A food grade plastic wrap will be applied across the walls of the basinet to create a microenvironment of increased humidity and decreased air movement. This is known as cling wrap. So in control arm, babies will be kept under radiant warmer whose basinet is covered with cling wrap for first 7 days of life. 
Intervention  Intervention arm  In addition to radiant warmer and cling wrap, babies will be covered from head to toe in another layer of occlusive plastic wrap in first 7 days of life. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  All inborn newborns of less than 32 weeks gestation and with birth weight less than or equal to 1200 grams born during the study period will be enrolled in the study. 
 
ExclusionCriteria 
Details  Major congenital anomalies
Fetal hydrops
Parental refusal of consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Average insensible water loss in first week of life  At the end of first week 
 
Secondary Outcome  
Outcome  TimePoints 
Hypothermia, hyperthermia, hyponatremia, hypernatremia, sepsis, cumulative weight loss, mortality and other neonatal morbidities  At the end of first week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 19/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/06/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Preterm newborns are subjected to significant thermal stress beginning from birth till their discharge from hospital. Most vulnerable period is right at birth in the labor room (LR) or operation theatre (OT) which is usually maintained at the comfort level for the caregivers. Newborns are subjected to all the processes of heat loss at LR/OT. Evaporative loss from skin and respiratory tract is the major cause of hypothermia and excessive weight loss of extremely preterm infants in first weeks of life. A food grade plastic wrap to cover the preterm infant from neck to foot without drying at birth is most widely used and significantly reduces incidence of admission hypothermia. However combined use of cling wrap and plastic wrap in preterm infants in the first postnatal period is not yet standardized because of fear of hyperthermia, sepsis and skin rash. Combined use of polyethylene occlusive wrap along with cling wrap might reduce insensible water loss (IWL) more effectively than cling wrap alone in an open care setting in postnatal period. However, there is no head to head comparison between these 2 approaches in first few weeks of life.  
Parents will be counselled before birth regarding the importance of maintaining thermal comfort for the baby in postnatal life. Gestational age will be checked before birth by first trimester dating scan and LMP. Best obstetric estimate of gestational age will be taken. If the baby is anticipated to be < 32 weeks, a neonatologist fellow will attend the delivery. Baby will be received in a polyethylene occlusive plastic wrap without drying and standard NRP 2020 guidelines will be followed for resuscitation. After excluding exclusion criteria parents will be approached for written informed consent. If refused, baby will not be enrolled in the study. Babies will be randomized in intervention(cling plus occlusive plastic wrap under radiant warmer) and control arm(only cling wrap under radiant warmer). This allocation will continue for the first seven days of life. Thereafter babies will be kept as per the discretion of the treating physician. 
Babies will be monitored for serious and significant adverse events. Serious adverse effects  will include any cause mortality, consecutive weight gain by >3 % for 3 consecutive days, excessive daily weight loss of > 3% for 3 consecutive days, excessive cumulative weight loss > 20%. Significant adverse effects will include any incidence of severe hyponatremia (< 120 meq/L), severe hypernatremia (> 150 meq/L), severe hyperthermia(> 390C), severe hypothermia (<320C).   Significant increase in serious and significant adverse effects  in  any group will prompt the investigators to stop the trial. An interim analysis is planned at 50% of sample recruitment.

 


 
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