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CTRI Number  CTRI/2019/06/019822 [Registered on: 24/06/2019] Trial Registered Prospectively
Last Modified On: 26/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different forms of chlorhexidine solution for skin antisepsis in neonates 
Scientific Title of Study   Efficacy of two different chlorhexidine gluconate preparations for skin antisepsis in neonates: a non inferiority 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  Akash Sharma 
Designation  Senior resident (DM) 
Affiliation  Division of Neonatology, Department of Pediatrics,AIIMS, New Delhi 
Address  Room no . 3058, 3rd floor teaching block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  drakash.jpr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anu Sachdeva 
Designation  Assistant Professor 
Affiliation  Division of Neonatology, Department of Pediatrics,AIIMS, New Delhi 
Address  Newborn health and knowledge centre( NHKC), 1st floor New private ward, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  dranuthukral@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anu Sachdeva 
Designation  Assistant Professor 
Affiliation  Division of Neonatology, Department of Pediatrics,AIIMS, New Delhi 
Address  Newborn health and knowledge centre( NHKC), 1st floor New private ward, All India Institute of Medical Sciences, New Delhi


DELHI
110029
India 
Phone    
Fax    
Email  dranuthukral@gmail.com  
 
Source of Monetary or Material Support  
All India Instiute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi 
 
Primary Sponsor  
Name  All India Instiute of Medical Sciences AIIMS New Delhi 
Address  Room No. 3058,Division of Neonatology,Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 
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 
Akash Sharma  All India Institute Of Medical Sciences,New Delhi  Room number 3058, 3rd floor Teaching Block,Division of Neonatology, Department of Pediatrics AlIMS, New Delhi
South
DELHI 
9887248273

drakash.jpr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee,AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  neonates admitted in the hospital for more than 48 hours 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1% chlorhexidine gluconate in aqueous form  Routine - Local application to skin Dose- around 0.5 to 1 ml applied to skin and dried Frequency- once per enrollment Duration- once Baby can be enrolled upto 28 days of life (for the same baby to be enrolled again a minimum time interval from last exposure should be 4 days) 
Comparator Agent  2% chlorhexidine gluconate in aqueous form   Routine - Local application to skin Dose- around 0.5 to 1 ml applied to skin and dried Frequency- once per enrollment Duration- once Baby can be enrolled upto 28 days of life (for the same baby to be enrolled again a minimum time interval from last exposure should be 4 days) 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  1) All inborn neonates from 26 0/7 - 42 6/7 weeks of gestation requiring NICU admission for at least 48 hrs

2) All extramural neonates from 26 0/7 - 42 6/7 weeks of gestation requiring admission in PICU/Pediatric surgery ICU/Pediatric HDU/Pediatric emergency irrespective of the duration of stay 
 
ExclusionCriteria 
Details  1) Hydrops
2) Generalised skin disorder
3) Skin infection
4) Severe persistent pulmonary hypertension
5) Sick baby requiring high ventilator support as adjudged by the clinical team 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the proportion of negative post cleansing skin swabs after the skin antisepsis performed by 1% aqueous chlorhexidine gluconate v/s 2 % aqueous chlorhexidine gluconate in neonates 26 0/7-42 6/7 weeks of gestation in first 28 days of life  post antisepsis skin swab will be taken after 2 minutes of chlorhexidine application 
 
Secondary Outcome  
Outcome  TimePoints 
To compare local skin reaction to chlorhexidine gluconate application  At 0,6,12,24 hours after chlorhexidine application 
Chlorhexidine level estimation in a subset of patients   at 6,12,24-48 hours after chlorhexidine application 
 
Target Sample Size   Total Sample Size="850"
Sample Size from India="850" 
Final Enrollment numbers achieved (Total)= "685"
Final Enrollment numbers achieved (India)="685" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/06/2019 
Date of Study Completion (India) 31/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Will be published after completion in a peer reviewed journal 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The primary outcome was proportion of negative skin swab cultures after skin antiseptic application with an absolute non inferiority limit of 5%. Secondary outcomes were local skin reaction at 0,6,12 and 24 hours and plasma chlorhexidine levels in a subset of study population at 6, 12 and 24 hours after application. 

Three hundred-eight neonates randomised on six hundred and eighty-five occasions (1% CHG: n=341; 2% CHG: n=344) were included in the analysis. The median (IQR) gestation age of enrolled infants was 34 (31-37) weeks. Proportion of negative skin swabs after application of 1% CHG and 2% CHG was 93% and 95.6% respectively (Risk difference 2.67%, 95% CI -0.79% to +6.15%). A total of 16 (2.3%) neonates developed mild dermatitis and none had severe dermatitis. There was no significant difference in median (IQR) plasma CHG levels; 19.6 ng/mL (12.5-36.3) vs. 12.6 ng/mL (8.7-26.5) in 1% CHG (n=24) and 2% CHG (n=17) groups.

Application of 1% aqueous CHG was neither inferior nor non inferior to 2% chlorhexidine aqueous for skin antisepsis in neonates, considering a noninferiority limit of 5%. No serious skin related adverse events were noted.

 


 
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