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

Completed

• Conditions: Pregnancy and Childbirth; mbilical cord care of the newborn; Umbilical cord care

• Registration Number: ISRCTN63012285
• Lead Sponsor: Riemser AG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 670

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cord separation time

Secondary Outcome Measures

Name	Time	Method
1. Frequency of omphalitis (and their symptoms: erythema, oedema, tenderness, secretion)<br>2. Signs of ulceration, granulomas<br>3. Parents' acceptance of treatment and satisfaction with treatment<br>4. Adverse events, overall assessment of tolerability by the physician and the patient's parents