Ignite Creation Date:
2024-05-06 @ 1:05 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01723501
Status:
WITHDRAWN
Last Update Posted:
2016-07-18
First Post:
2012-11-06
Brief Title:
Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing 1500 g at Birth
Sponsor:
All India Institute of Medical Sciences New Delhi
Organization:
All India Institute of Medical Sciences New Delhi
Study Overview
Official Title:
Whole Body Cleansing With 025 Chlorhexidine at Birth for Prevention of Sepsis in Infants 1500 g a Multi-center Blinded Randomized Trial
Status:
WITHDRAWN
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not started and prematurely closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPS
Brief Summary:
Purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing 1500 g at birth
Detailed Description:
Background
Infants weighing 1500 g at birth infants are more prone to acquire infections often through their immature skin which serve as a portal of entry for invasive pathogens Skin application of antiseptics such as chlorhexidine may reduce infections in these infants However there is a paucity of data on the safety and efficacy of such intervention in these infants
Hypothesis
Among hospitalized very low birth weight VLBW 1500 g neonates single whole body skin cleansing with 025 chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25 to 175 relative reduction of 30 when compared to skin cleansing with sterile water
Objectives
Primary- To evaluate the effect of whole body skin cleansing with 025 chlorhexidine single application at birth on the incidence of sepsis culture positive or culture negative compared to sterile water cleansing in the first week of life in VLBW infants
Secondary- to compare following outcomes in this experiment
1 Culture-confirmed sepsis within the first week of life
2 Need for repeat hospital admissions within first 28 days of life
3 Mortality within first 28 days of life
4 Cold stresshypothermia at 0 5 15 and 30 minutes of intervention
5 Skin condition at 24 h of life
6 Colonization rates subset
7 Serum levels of chlorhexidine subset
Methods
Eligible infants would be randomized within 6 hours of birth to either whole body skin cleansing with chlorhexidine specially prepared wipes releasing 025 chlorhexidine or sterile water placebo The research staff would collect the baseline data record the axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring NSCSscore The research team would follow the infants for development of sepsis and other outcomes The infants would be subjected to detailed sepsis work up on clinical suspicion of sepsis until 28 days of life
Sepsis would be defined based on combination of clinical course indirect markers bacterial culture results and antibiotic treatment status
Infants weighing 1500 g at birth infants are more prone to acquire infections often through their immature skin which serve as a portal of entry for invasive pathogens Skin application of antiseptics such as chlorhexidine may reduce infections in these infants However there is a paucity of data on the safety and efficacy of such intervention in these infants
Hypothesis
Among hospitalized very low birth weight VLBW 1500 g neonates single whole body skin cleansing with 025 chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25 to 175 relative reduction of 30 when compared to skin cleansing with sterile water
Objectives
Primary- To evaluate the effect of whole body skin cleansing with 025 chlorhexidine single application at birth on the incidence of sepsis culture positive or culture negative compared to sterile water cleansing in the first week of life in VLBW infants
Secondary- to compare following outcomes in this experiment
1 Culture-confirmed sepsis within the first week of life
2 Need for repeat hospital admissions within first 28 days of life
3 Mortality within first 28 days of life
4 Cold stresshypothermia at 0 5 15 and 30 minutes of intervention
5 Skin condition at 24 h of life
6 Colonization rates subset
7 Serum levels of chlorhexidine subset
Methods
Eligible infants would be randomized within 6 hours of birth to either whole body skin cleansing with chlorhexidine specially prepared wipes releasing 025 chlorhexidine or sterile water placebo The research staff would collect the baseline data record the axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring NSCSscore The research team would follow the infants for development of sepsis and other outcomes The infants would be subjected to detailed sepsis work up on clinical suspicion of sepsis until 28 days of life
Sepsis would be defined based on combination of clinical course indirect markers bacterial culture results and antibiotic treatment status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None