Treating the Resistant Patent Ductus Arteriosus (PDA)

Tracking Information
First Submitted Date ICMJE	January 13, 2008
First Posted Date ICMJE	February 15, 2008
Last Update Posted Date	February 15, 2008
Study Start Date ICMJE	March 2008
Estimated Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 14, 2008)	Our primary objective in this study is to improve ductal closure rates in those infants who do not respond to a first course of therapy. [ Time Frame: 2 years ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: February 14, 2008)	Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols. [ Time Frame: 2 years ]; To monitor and compare potential side effects of the two treatment approaches [ Time Frame: 2 years ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Treating the Resistant Patent Ductus Arteriosus (PDA)
Official Title ICMJE	New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates
Brief Summary	Persistent postnatal ductal patency may have significant adverse hemodynamic effects, frequently necessitating therapeutic intervention in order to facilitate ductal closure. Medical therapy for patency of the ductus arteriosus is successful mediating ductal closure in approximately 70% of treated infants. In a recent study in our population, 17% of the babies showed no ductal response to the first course of treatment and 9.4% of our study infants eventually underwent surgical ligation of the ductus after failure of medical therapeutic closure.We propose to evaluate and compare two alternate therapeutic approaches to ductal closure in babies who do not respond to initial therapy.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Patent Ductus Arteriosus
Intervention ICMJE	Drug: Indomethacin IV indomethacin starting at a dose of 0.4 mg/kg given over 30 minutes, increased daily by increments of 0.2 mg/kg/dose and given at intervals of 12 hours until a maximum dose of 1 mg/kg is reached, or until a total indomethacin dose of 6 mg/kg has been given. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later, using the same dose used in the last indomethacin infusion.; Drug: Pentoxifylline IV indomethacin will be re-started at a dose of 0.2 mg/kg to run over 30 minutes at 12 hour intervals to be given concurrently with pentoxifylline (5 mg/kg/hour to run over 6 hour once a day for a maximum of 6 days. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later and another day of pentoxifylline infusion, provided that the 6 day maximum has not yet been
Study Arms	Experimental: Stepwise Indo Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose. Intervention: Drug: Indomethacin; Experimental: PTX Combined administration of indomethacin and pentoxifylline, an inhibitor of TNF alpha Intervention: Drug: Pentoxifylline
Publications *	Sperandio M, Beedgen B, Feneberg R, Huppertz C, Brüssau J, Pöschl J, Linderkamp O. Effectiveness and side effects of an escalating, stepwise approach to indomethacin treatment for symptomatic patent ductus arteriosus in premature infants below 33 weeks of gestation. Pediatrics. 2005 Dec;116(6):1361-6.; Gonzalez A, Sosenko IR, Chandar J, Hummler H, Claure N, Bancalari E. Influence of infection on patent ductus arteriosus and chronic lung disease in premature infants weighing 1000 grams or less. J Pediatr. 1996 Apr;128(4):470-8.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: February 14, 2008)	68
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Inborn premature neonates admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as having a hemodynamically significant patent ductus arteriosus (sPDA) will be considered as potential candidates for study if/when they do not respond to initial therapy Exclusion Criteria: Any baby not considered viable; Any baby with IVH grade 3-4 of recent onset (within 3 days. [If no head ultrasound has been performed within the last 3-4 days, one should performed prior to onset of study.]; Any baby with dysmorphic features or congenital abnormalities; Any baby with structural heart disease other than PDA; Any baby with documented infection,; Any baby with thrombocytopenia (<50,000).
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 4 Weeks (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Israel
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00616382
Other Study ID Numbers ICMJE	CHPDA2
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Cathy Hammerman, Shaare Zedek Medical Center
Study Sponsor ICMJE	Shaare Zedek Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center
PRS Account	Shaare Zedek Medical Center
Verification Date	January 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP