Hyperbilirubinemia
Conditions
Interventions
Trade Name: Rocephin
Product Name: Ceftriaxone
Product Code: J01DD04
Pharmaceutical Form: Concentrate for suspension for infusion
Sponsors
St. Elisabeth Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Contacts
Public ContactDr. Obihara, pediatrician
St. Elisabeth Hospital
Outcome results
None listed