Blood stream infections in neonates
Conditions
Interventions
Trade Name: ChloraPrep® 2% w/v / 70% v/v cutaneous solution
Product Name: ChloraPrep® 2% w/v / 70% v/v cutaneous solution
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Chlorhexidine
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the use of 2% chlorhexidine in 70% isopropyl alcohol compared to 10% povidone-iodine for skin antisepsis prior to central venous catheter insertion results in fewer catheter related blood stream infections in infants 15 colonies of a pure growth of the same | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints for this study are assessment of the following parameters in relation to catheter related blood stream infections: o Number of CVC insertions, attempted and successful o Duration CVC in situ (days) o Number of blood cultures taken o Episodes of positive blood culture and = 5 days of antibiotics o Number of courses of antibiotics o Duration of antibiotic therapy (days) o Skin reactions to cleansing solutions o Number of CSF confirmed infections o Pericardial effusions o Pleural effusions o Bacterial endocarditis o Raised thyroid stimulating hormone levels on newborn screening (Guthrie) card o Duration of mechanical ventilation (days) o Duration of CPAP (days) o Duration of oxygen therapy (days) o Oxygen therapy at 28 days of age o Oxygen therapy 36 weeks’ post-menstrual age o Home oxygen therapy required upon discharge o Air leaks o Medical and surgical treatment for patent ductus arteriosus o Duration receiving parenteral nutrition (days) o Time to 120mL/kg/day enteral feeds o Gastrointestinal perforation o Necrotising enterocolitis o Cranial ultrasound abnormalities (intraventricular hemorrhage and periventricular leukomalacia) o Retinopathy of prematurity o Duration of hospital stay (days) o Death before discharge ;Timepoint(s) of evaluation of this end point: These secondary endpoints will be assessed from time of insertion of first CVC until death or discharge. | — |
Countries
Ireland
Contacts
Public ContactClinical Trials Information
Java Clinical Research
Outcome results
None listed