Treating the Resistant Patent Ductus Arteriosus (PDA)

Patent Ductus Arteriosus Clinical Trial

Official title:

New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00616382
• Other study ID #: CHPDA2
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 13, 2008
• Last updated: February 14, 2008
• Start date: March 2008

Study information

• Verified date: January 2008
• Source: Shaare Zedek Medical Center
• Contact: Cathy Hammerman, MD
• Phone: 9722 6666238
• Email: cathy[@]cc.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

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.
• 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

Locations

Country	Name	City	State
Israel	Neonatal Intensive Care Unit - Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No
Secondary	Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols.		2 years	No
Secondary	To monitor and compare potential side effects of the two treatment approaches		2 years	Yes