Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00947518
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : July 28, 2009
Last Update Posted : June 25, 2018
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Neonatal Sepsis
Low Birth Weight
Interventions Drug: Chlorhexidine
Drug: Normal saline
Enrollment 60
Recruitment Details 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 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
Arm/Group Title Chlorhexidine Skin Cleansing Saline Skin Cleansing No Skin Cleansing
Hide Arm/Group Description Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate) Wiping the skin (except the face) using baby wipes containing normal saline No skin application
Period Title: Overall Study
Started 20 20 20
Completed 20 20 20
Not Completed 0 0 0
Arm/Group Title Chlorhexidine Skin Cleansing Saline Skin Cleansing No Skin Cleansing Total
Hide Arm/Group Description Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate) Wiping the skin (except the face) using baby wipes containing normal saline No skin application Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
<=18 years
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
7
  35.0%
11
  55.0%
11
  55.0%
29
  48.3%
Male
13
  65.0%
9
  45.0%
9
  45.0%
31
  51.7%
Gestation (weeks)   [1] 
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 20 participants 20 participants 20 participants 60 participants
33
(28 to 36)
33
(28 to 36)
32.5
(28 to 36)
33
(28 to 36)
[1]
Measure Description: Estimated gestational age in completed weeks
1.Primary Outcome
Title Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al
Hide Description The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)
Time Frame At 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine Skin Cleansing Saline Skin Cleansing No Skin Cleansing
Hide Arm/Group Description:
Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Wiping the skin (except the face) using baby wipes containing normal saline
No skin application
Overall Number of Participants Analyzed 20 20 20
Median (Full Range)
Unit of Measure: score on a scale
1
(1 to 2)
1
(1 to 3)
1
(1 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorhexidine Skin Cleansing, Saline Skin Cleansing, No Skin Cleansing
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Primary Outcome
Title Skin Temperature at 30 Min After Intervention
Hide Description Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes
Time Frame at 30 min after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine Skin Cleansing Saline Skin Cleansing No Skin Cleansing
Hide Arm/Group Description:
Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Wiping the skin (except the face) using baby wipes containing normal saline
No skin application
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
36.6  (0.2) 36.6  (0.12) 36.7  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorhexidine Skin Cleansing, Saline Skin Cleansing, No Skin Cleansing
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With Positive Skin Culture at Axilla
Hide Description Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention
Time Frame 24 hours after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine Skin Cleansing Saline Skin Cleansing No Skin Cleansing
Hide Arm/Group Description:
Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Wiping the skin (except the face) using baby wipes containing normal saline
No skin application
Overall Number of Participants Analyzed 18 19 19
Measure Type: Number
Unit of Measure: participants
4 10 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorhexidine Skin Cleansing, Saline Skin Cleansing, No Skin Cleansing
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Incidence of Clinical and Culture Positive Sepsis
Hide Description Infants with symptoms and/or signs suggestive of sepsis and a positive blood culture (with known pathogens and coagulase negative staphylococcus) were diagnosed to have culture positive sepsis; Those with negative cultures but with positive sepsis screen were classified as having clinical sepsis
Time Frame First week of life
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine Skin Cleansing Saline Skin Cleansing No Skin Cleansing
Hide Arm/Group Description:
Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
Wiping the skin (except the face) using baby wipes containing normal saline
No skin application
Overall Number of Participants Analyzed 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
Culture-positive sepsis
1
   5.0%
2
  10.0%
2
  10.0%
Clinical sepsis
2
  10.0%
3
  15.0%
1
   5.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorhexidine Skin Cleansing, Saline Skin Cleansing, No Skin Cleansing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Other Statistical Analysis For comparison of categorical variables among the three groups, Chi2 test followed by Bonferroni’s correction was used.
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
Responsible Party: M Jeeva Sankar, Department of Pediatrics, AIIMS, New Delhi
ClinicalTrials.gov Identifier: NCT00947518     History of Changes
Other Study ID Numbers: 10/2004
First Submitted: April 20, 2009
First Posted: July 28, 2009
Results First Submitted: April 20, 2009
Results First Posted: July 28, 2009
Last Update Posted: June 25, 2018