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CTRI Number  CTRI/2020/10/028719 [Registered on: 29/10/2020] Trial Registered Prospectively
Last Modified On: 28/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to understand if a new method of application of 1 % chlorhexidine solution for skin cleaning in newborn babies would result in lower blood levels of chlorhexidine without decreasing its antiseptic property when compared to the standard method of applying it. 
Scientific Title of Study   Antiseptic efficacy and plasma chlorhexidine levels following two different methods of application of 1 % aqueous chlorhexidine gluconate for skin disinfection in preterm newborns: A blinded, parallel group, randomized trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RICHIE DALAI 
Designation  DM SENIOR RESIDENT NEONATOLOGY 
Affiliation  AIIMS NEW DELHI 
Address  NHKC,First Floor, New Private Ward, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9914842233  
Fax    
Email  richie.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  RAMESH AGARWAL 
Designation  PROFESSOR, Division of Neonatology, Department of Pediatrics 
Affiliation  AIIMS NEW DELHI 
Address  NHKC,First Floor, New Private Ward, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810756718  
Fax    
Email  ra.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  RAMESH AGARWAL 
Designation  PROFESSOR, Division of Neonatology, Department of Pediatrics 
Affiliation  AIIMS NEW DELHI 
Address  NHKC,First Floor, New Private Ward, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9810756718  
Fax    
Email  ra.aiims@gmail.com  
 
Source of Monetary or Material Support  
Department of Microbiology, AIIMS New Delhi 
Division of Neonatology, Department of Pediatrics, AIIMS New Delhi 
Ocular Pharmacy, RPC, AIIMS New Delhi 
 
Primary Sponsor  
Name  Department of Pediatrics 
Address  AIIMS, ANSARI NAGAR EAST, New Delhi- 110029 
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 
RICHIE DALAI  AIIMS NEW DELHI  ROOM 3057 A, 3rd Floor, Teaching Block, Division of Neonatology, Department Of Pediatrics
New Delhi
DELHI 		 9914842233

richie.aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for post graduate research, AIIMS NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Air Drying of 1 % aqueous chlorhexidine post application  Application of 1 % aqueous chlorhexidine for skin antisepsis in preterm neonates 28-34 weeks gestation followed by air drying for 2 minutes without wiping off residual chlorhexidine with sterile water swab  
Intervention  Wiping off 1 % chlorhexidine with sterile water swab post application  Sequential application of 1 % aqueous chlorhexidine for skin antisepsis in preterm neonates 28-34 weeks gestation followed by wiping with a sterile water swab after 2 minutes duration  
 
Inclusion Criteria  
Age From  2.00 Day(s)
Age To  14.00 Day(s)
Gender  Both 
Details  1) All neonates born inside at 28 0/7 to 34 6/7 weeks GA ,at least 48 hours of age & before 2 weeks post natal age

2) All neonates born outside at 28 0/7 to 34 6/7 weeks GA, at admission to NICU and pediatric surgical ICU & before 2 weeks post natal age
 
 
ExclusionCriteria 
Details  Disorders of skin
Local skin infection
Hydrops
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Plasma chlorhexidine level (ng/mL) determined by HPLC/MS

2)Proportion of negative post antisepsis skin swabs (≤15 CFU/mL)

 		 1) 12 hours post exposure for plasma chlorhexidine levels

2) Just before and after application of 1 % aqueous Chlorhexidine in any of the above two methods for skin swab collection 
 
Secondary Outcome  
Outcome  TimePoints 
Local skin reaction by visual inspection and dermatitis scoring  0(±1), 6(±1), 12(±1) hours post exposure 
 
Target Sample Size   Total Sample Size="560"
Sample Size from India="560" 
Final Enrollment numbers achieved (Total)= "560"
Final Enrollment numbers achieved (India)="457" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2020 
Date of Study Completion (India) 31/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 Study plan: This is a randomized control trial to compare two different methods of application of 1 % aqueous CHG for local skin disinfection in preterm neonates, in terms of antiseptic efficacy and systemic absorption of chlorhexidine. 

There is no consensus as to which agent should be used for local skin antisepsis in neonates. Currently povidone iodine and alcohol swabs are being used in many units in India but they can cause hypothyroidism and skin burns respectively. Thus, in this subgroup of preterm neonates 1 % aqueous chlorhexidine is an effective alternative as per available evidence. But, it has been seen that even with 1 % solution of chlorhexidine gluconate there can be systemic absorption and a safe upper limit of plasma chlorhexidine is not yet known. 

Our aim is to find a way to reduce this systemic absorption as far as possible, by seeing if application of chlorhexidine followed by wiping with sterile water swab decreases this systemic absorption of chlorhexidine compared to the standard method of air drying the antiseptic agent after application, without decreasing its antiseptic efficacy. 

This will be a superiority trial (by margin of 50 %) for reduction in plasma chlorhexidine levels and a non inferiority trial (by a margin of 5 %) for antisepsis efficacy.

Sample size for seeing if the intervention reduced plasma chlorhexidine levels is 90 and that for proving its non inferiority in terms of antisepsis efficacy is 560.

Current status: The study was completed in July 2022. A total of 457 enrollments were done in 229 neonates. Cleansing was not found to be non-inferior to the standard method in terms of skin anti-sepsis. Plasma chlorhexidine levels were not found to be different significantly between both groups.
 
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