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Treating the Resistant Patent Ductus Arteriosus (PDA)

Primary Purpose

Patent Ductus Arteriosus

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Indomethacin

Pentoxifylline

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring PDA, indomethacin, pentoxifylline, Patent Ductus Arteriosus [PDA] resistant to therapy

Eligibility Criteria

2 Days - 4 Weeks (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Neonatal Intensive Care Unit - Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Stepwise Indo

PTX

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00616382

First Posted

January 13, 2008

Last Updated

February 14, 2008

Sponsor

Shaare Zedek Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00616382

Brief Title

Treating the Resistant Patent Ductus Arteriosus (PDA)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2008 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patent Ductus Arteriosus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stepwise Indo

Arm Type

Experimental

Arm Description

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

Arm Title

PTX

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Indomethacin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Days

Maximum Age & Unit of Time

4 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cathy Hammerman, MD

Phone

9722 6666238

cathy@cc.huji.ac.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cathy Hammerman, MD

Organizational Affiliation

Shaare Zedek Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neonatal Intensive Care Unit - Shaare Zedek Medical Center

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cathy Hammerman, MD

First Name & Middle Initial & Last Name & Degree

Irina Schorrs, MD

First Name & Middle Initial & Last Name & Degree

Amiram Nir, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

16322159

Citation

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.

Results Reference

result

PubMed Identifier

8618179

Citation

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.

Results Reference

result

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Treating the Resistant Patent Ductus Arteriosus (PDA)

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