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Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00947518
First received: April 20, 2009
Last updated: July 27, 2009
Last verified: June 2009
Results First Received: April 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Neonatal Sepsis
Low Birth Weight
Interventions: Drug: Chlorhexidine
Drug: Normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
from August 2005 to February 2006 at the tertiary level neonatal intensive care unit of All India Institute of Medical Sciences, New Delhi

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Infants with one minute Apgar score <4, hemodynamic instability, congenital malformations, generalized skin disorder and who needed respiratory support (continuous positive airway pressure and/or intermittent mandatory ventilation) were excluded

Reporting Groups
  Description
Chlorhexidine Skin Cleansing Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Saline Skin Cleansing Wiping the skin (except the face) using baby wipes containing normal saline
No Skin Cleansing No skin application

Participant Flow:   Overall Study
    Chlorhexidine Skin Cleansing     Saline Skin Cleansing     No Skin Cleansing  
STARTED     20     20     20  
COMPLETED     20     20     20  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chlorhexidine Skin Cleansing Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Saline Skin Cleansing Wiping the skin (except the face) using baby wipes containing normal saline
No Skin Cleansing No skin application
Total Total of all reporting groups

Baseline Measures
    Chlorhexidine Skin Cleansing     Saline Skin Cleansing     No Skin Cleansing     Total  
Number of Participants  
[units: participants]
  20     20     20     60  
Age  
[units: participants]
       
<=18 years     20     20     20     60  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     7     11     11     29  
Male     13     9     9     31  
Gestation (weeks) [1]
[units: weeks]
Median ( Full Range )
  33  
  ( 28 to 36 )  
  33  
  ( 28 to 36 )  
  32.5  
  ( 28 to 36 )  
  33  
  ( 28 to 36 )  
[1] Estimated gestational age in completed weeks



  Outcome Measures
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1.  Primary:   Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al   [ Time Frame: At 24 hours ]

2.  Primary:   Skin Temperature at 30 Min After Intervention   [ Time Frame: at 30 min after intervention ]

3.  Primary:   Number of Participants With Positive Skin Culture at Axilla   [ Time Frame: 24 hours after intervention ]

4.  Secondary:   Incidence of Clinical and Culture Positive Sepsis   [ Time Frame: First week of life. ]
Results not yet reported.   Anticipated Reporting Date:   09/2009   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mari Jeeva Sankar
Organization: Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
phone: +91-11-26594372
e-mail: jeevasankar@gmail.com


No publications provided


Responsible Party: M Jeeva Sankar, Department of Pediatrics, AIIMS, New Delhi
ClinicalTrials.gov Identifier: NCT00947518     History of Changes
Other Study ID Numbers: 10/2004
Study First Received: April 20, 2009
Results First Received: April 20, 2009
Last Updated: July 27, 2009
Health Authority: India: Institutional Review Board