Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Final version 16/04/2003
Study information
Scientific title
Acronym
IPSS C 002
Study hypothesis
The primary objective of this trial is to show the superiority of chlorhexidine powder over a non-treated (dry care) control group regarding the separation time of the umbilical cord stump.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Umbilical cord care of the newborn
Intervention
Topical umbilical cord care with 1 g chlorhexidine powder or dry care with every diaper change (not less than 3 diaper changes per day) by the nurses and midwives in the nursery and by the parents at home for at least 3 days following cord detachment versus dry care of the umbilical cord.
Intervention type
Drug
Phase
Not Specified
Drug names
Chlorhexidine powder
Primary outcome measure
Cord separation time
Secondary outcome measures
1. Frequency of omphalitis (and their symptoms: erythema, oedema, tenderness, secretion)
2. Signs of ulceration, granulomas
3. Parents' acceptance of treatment and satisfaction with treatment
4. Adverse events, overall assessment of tolerability by the physician and the patient's parents
Overall trial start date
01/10/2003
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy newborns on the first day of life
2. Gestational age: 37-42 weeks
3. Birth weight >2500 g
4. Informed consent given in a written form by both parents after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
670
Participant exclusion criteria
1. Current participation in another clinical trial
2. Signs of clinically relevant illnesses (excluding physiological neonatal hyperbilirubinemia)
3. Evidence for HIV- or Hepatitis B/C-infection
4. Evidence for infection of the newborn (also expected antibiotic therapy)
5. Treatment of the subject with systemic antibiotics
6. Treatment of the umbilical cord with local antimicrobial regimen before randomization
7. Twins or triplets
8. Delivery at home
9. Legal incapacity and/or other circumstances rendering the subjects parents unable to understand the nature, scope and possible consequences of the study
10. Unreliability or lack of cooperation from the parents
11. Any other condition which, in the opinion of the investigator, would render the subject ineligible for the study
Recruitment start date
01/10/2003
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Childrens Hospital University of Leipzig
Leipzig
D-04103
Germany
Sponsor information
Organisation
Riemser AG (Germany)
Sponsor details
An der Wiek 7
Greifswald- Insel Riems
D-17493
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Riemser AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19202343
Publication citations
-
Results
Kapellen TM, Gebauer CM, Brosteanu O, Labitzke B, Vogtmann C, Kiess W, Higher rate of cord-related adverse events in neonates with dry umbilical cord care compared to chlorhexidine powder. Results of a randomized controlled study to compare efficacy and safety of chlorhexidine powder versus dry care in umbilical cord care of the newborn., Neonatology, 2009, 96, 1, 13-18, doi: 10.1159/000200165.