Treating the Resistant Patent Ductus Arteriosus (PDA)

NCT00616382 | Unknown Phase 2 DMC

• 1 other identifier: CHPDA2
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Patent Ductus Arteriosus

Keywords

PDA; indomethacin; pentoxifylline; Patent Ductus Arteriosus [PDA] resistant to therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols.

  2 years

• To monitor and compare potential side effects of the two treatment approaches

  2 years

Study Arms (2)

Stepwise Indo

EXPERIMENTAL

Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose.

Drug: Indomethacin

PTX

EXPERIMENTAL

Combined administration of indomethacin and pentoxifylline, an inhibitor of TNF alpha

Drug: Pentoxifylline

Interventions

Indomethacin DRUG

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.

Stepwise Indo

Pentoxifylline DRUG

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

PTX

Eligibility Criteria

• Age: 2 Days - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Neonatal Intensive Care Unit - Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (2)

• Sperandio M, Beedgen B, Feneberg R, Huppertz C, Brussau J, Poschl 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. doi: 10.1542/peds.2005-0293.

  PMID: 16322159 RESULT

• 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. doi: 10.1016/s0022-3476(96)70356-6.

  PMID: 8618179 RESULT

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Indomethacin; Pentoxifylline

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Theobromine; Xanthines; Purinones; Purines

Study Officials

• Cathy Hammerman, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Hammerman, MD

CONTACT

9722 6666238; cathy@cc.huji.ac.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2008
• First Posted: February 15, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Last Updated: February 15, 2008

Record last verified: 2008-01

Locations

IL (1)