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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Christian Vogtmann
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Chlorhexidine powder
Primary outcome measure(s)	Cord separation time
Key secondary outcome measure(s)	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
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Childrens Hospital University of Leipzig

Leipzig
D-04103
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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