CEFTRIAXONE NEONATAL THERAPY: A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF CEFTRIAXONE ON HYPERBILIRUBINEMIA
- Conditions
- HyperbilirubinemiaTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2011-004417-16-NL
- Lead Sponsor
- St. Elisabeth Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
All neonates, 0-28 days old, with a gestational age (GA) of = 34 weeks, admitted to the neonatal unit and requiring antibiotic treatment for a serious bacterial infection
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
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
Gestational age <34 weeks; congenital malformations; erythrocyte transfusion; blood group or other types of antibody antagonism; haemoglobinopathy; malignancy; serious perinatal asphyxia ; concomitant use of intravenous calcium containing solutions (intravenous fluid or total parenteral nutrition) or transfer to another hospital before completion of study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: development of neonatal hyperbilirubinaemia requiring antibiotic treatment;Secondary Objective: development of pseudolithiasis in the biliary and urogenital tracts;Primary end point(s): the incidence of hyperbilirubinemia between neonates treated with ceftriaxon- augmentin combination and those treated with tobramycin- augmentin combination. ;Timepoint(s) of evaluation of this end point: Day 1, day 3 and day 7.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Incidence of pseudolithiasis of the biliary and urogenital tract and laboratory abnormalities between neonates treated with CFT-AUGM combination and those treated with TOBI-AUGM combination. ;Timepoint(s) of evaluation of this end point: Day 1, day 3 and day 7.