A randomised, double-blind, placebo-controlled trial of the effect of theophylline in prevention of vasomotor nephropathy in very preterm neonates with respiratory distress syndrome
DEC-NET Serial number IT406
Published online24/05/2005 11.25.00
Last updated25/05/2005 11.04.05
Other protocol ID number
Current trial statusComplete(closed to recruitment of participants: follow-up complete)
Major Disease
(ICD9 class)		ACUTE RENAL FAILURE WITH LESION OF TUBULAR NECROSI
Experimental drug
THEOPHYLLINE
GenderBoth
Age (range)Less than 32 weeks gestational age

Eligibility criteria
Inclusion criteria
- Inborn preterm neonates with less then/equal to 32 weeks gestational age - developed respiratory distress syndrome within 6 hours of birth and needed mechanical ventilation or nasal continuous positive airway pressure (nCPAP) - Parent.s/guardian.s informed consent
Exclusion criteria
- kidneys and/or urinary tract congenital abnormalities - congenital heart defects - prenatal exposure to ACE-inhibitors or non-steroidal anti-inflammatory drugs (NSAID) that can modify renal hemodynamics - chromosomal disorders or multiple malformations

Trial design/methodology
Phase4
Kind of studyEfficacy
Prophylaxis
DesignControlled
Randomised
Blinded
Double blind
Purpose of study
To evaluate the effect of theophylline in prevention of vasomotor nephropathy in very preterm neonates with respiratory distress syndrome
Summary of study design, objectives, and ongoing research findings
To evaluate the effect of theophylline, compared to placebo, in the prevention of vasomotor nephropathy in very preterm neonates with respiratory distress syndrome.
Principal investigator
NameDott. G. Chirico
InstitutionUnità Operativa di Neonatologia e Terapia Intensiva Neonatale - Azienda Ospedaliera Spedali Civili di Brescia
Postal addressP.le Spedali Civili 1
CityBrescia
CountryITALY
Phone+39 030/39951
Fax+39 030/303300
E-mail

ISRCTN  EudraCT