A randomised controlled study to compare efficacy and safety of chlorhexidine powder versus dry care in umbilical cord care of the newborn
ISRCTN | ISRCTN63012285 |
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DOI | https://doi.org/10.1186/ISRCTN63012285 |
Secondary identifying numbers | Final version 16/04/2003 |
- Submission date
- 06/09/2005
- Registration date
- 05/10/2005
- Last edited
- 10/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christian Vogtmann
Scientific
Scientific
Childrens Hospital University of Leipzig
Philipp-Rosenthal-Str. 55
Leipzig
D-04103
Germany
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | IPSS C 002 |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/10/2003 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 670 |
Key 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 |
Key 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 |
Date of first enrolment | 01/10/2003 |
Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Childrens Hospital University of Leipzig
Leipzig
D-04103
Germany
D-04103
Germany
Sponsor information
Riemser AG (Germany)
Industry
Industry
An der Wiek 7
Greifswald- Insel Riems
D-17493
Germany
Website | http://www.riemser.de |
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https://ror.org/01a7r5j51 |
Funders
Funder type
Industry
Riemser AG (Germany)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/07/2009 | Yes | No |