Trial Outcomes & Findings for Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants (NCT NCT00947518)

NCT ID: NCT00947518

Last Updated: 2018-06-25

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: At 24 hours
• Results posted on: 2018-06-25

Participant Flow

from August 2005 to February 2006 at the tertiary level neonatal intensive care unit of All India Institute of Medical Sciences, New Delhi

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

Participant milestones

Measure	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
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Chlorhexidine Skin Cleansing n=20 Participants Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)	Saline Skin Cleansing n=20 Participants Wiping the skin (except the face) using baby wipes containing normal saline	No Skin Cleansing n=20 Participants No skin application	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	31 Participants n=4 Participants
Gestation (weeks)	33 weeks n=5 Participants	33 weeks n=7 Participants	32.5 weeks n=5 Participants	33 weeks n=4 Participants

PRIMARY outcome

Timeframe: At 24 hours

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)

Outcome measures

Measure	Chlorhexidine Skin Cleansing n=20 Participants Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)	Saline Skin Cleansing n=20 Participants Wiping the skin (except the face) using baby wipes containing normal saline	No Skin Cleansing n=20 Participants No skin application
Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al	1 score on a scale Interval 1.0 to 2.0	1 score on a scale Interval 1.0 to 3.0	1 score on a scale Interval 1.0 to 2.0

PRIMARY outcome

Timeframe: at 30 min after intervention

Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes

Outcome measures

Measure	Chlorhexidine Skin Cleansing n=20 Participants Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)	Saline Skin Cleansing n=20 Participants Wiping the skin (except the face) using baby wipes containing normal saline	No Skin Cleansing n=20 Participants No skin application
Skin Temperature at 30 Min After Intervention	36.6 Degree Celsius Standard Deviation 0.2	36.6 Degree Celsius Standard Deviation 0.12	36.7 Degree Celsius Standard Deviation 0.24

PRIMARY outcome

Timeframe: 24 hours after intervention

Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention

Outcome measures

Measure	Chlorhexidine Skin Cleansing n=18 Participants Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)	Saline Skin Cleansing n=19 Participants Wiping the skin (except the face) using baby wipes containing normal saline	No Skin Cleansing n=19 Participants No skin application
Number of Participants With Positive Skin Culture at Axilla	4 participants	10 participants	11 participants

SECONDARY outcome

Timeframe: First week of life

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

Outcome measures

Measure	Chlorhexidine Skin Cleansing n=20 Participants Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)	Saline Skin Cleansing n=20 Participants Wiping the skin (except the face) using baby wipes containing normal saline	No Skin Cleansing n=20 Participants No skin application
Incidence of Clinical and Culture Positive Sepsis Culture-positive sepsis	1 Participants	2 Participants	2 Participants
Incidence of Clinical and Culture Positive Sepsis Clinical sepsis	2 Participants	3 Participants	1 Participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mari Jeeva Sankar

Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

Phone: +91-11-26594372

Email: jeevasankar@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place