A randomised controlled study to compare efficacy and safety of chlorhexidine powder versus dry care in umbilical cord care of the newborn

ISRCTN ISRCTN63012285
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

Childrens Hospital University of Leipzig
Philipp-Rosenthal-Str. 55
Leipzig
D-04103
Germany

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymIPSS C 002
Study objectivesThe 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) studiedUmbilical cord care of the newborn
InterventionTopical 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Chlorhexidine powder
Primary outcome measureCord separation time
Secondary outcome measures1. 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 date01/10/2003
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants670
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2003
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Childrens Hospital University of Leipzig
Leipzig
D-04103
Germany

Sponsor information

Riemser AG (Germany)
Industry

An der Wiek 7
Greifswald- Insel Riems
D-17493
Germany

Website http://www.riemser.de
ROR logo "ROR" https://ror.org/01a7r5j51

Funders

Funder type

Industry

Riemser AG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2009 Yes No