Umbilical cord care of the newborn Pregnancy and Childbirth Umbilical cord care
Conditions
Interventions
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
Sponsors
Riemser AG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cord separation time | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed