To compare the ability of two antispetic agents (Chlorohexidine and Povidone-iodine), when applied to the skin prior to insertion of a tube into a premature infant, to prevent infections in the blood stream.

• Conditions: Blood stream infections in neonates; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-002962-19-IE
• Lead Sponsor: niversity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-07
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria
Only infants who meet all of the following inclusion criteria will be eligible for enrolment into this study:
1. Born at < 31 weeks gestation (by best obstetric estimate)
2. Have a central venous catheter inserted (UVC or PICC) in the neonatal intensive care unit (NICU) of one of the participating centres.
3. Who’s parent/legal guardian are willing and able to understand and provide written, informed consent prior to their Infant’s participation in the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 304
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Infants meeting any of the following exclusion criteria are not eligible for enrolment into this study:

1. Infants with major congenital anomalies, including but not limited to gastroschisis, diaphragmatic hernia, oesophageal atresia, omphalocoele; tracheo-oesophageal fistula; neural tube defect; structural heart lesion other than patent ductus arteriosus or small atrial or ventricular septal defect.
2. Infants who have previously had a CVC placed at a participating or referring hospital.
3. Infants who are participating in another clinical trial involving an investigational medicinal product.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified