Condition category
Pregnancy and Childbirth
Date applied
06/09/2005
Date assigned
05/10/2005
Last edited
10/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christian Vogtmann

ORCID ID

Contact details

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

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 measures

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

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

http://www.riemser.de

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19202343

Publication citations

  1. 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.

Additional files

Editorial Notes