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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
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
Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols.
Condition
Patent Ductus Arteriosus
Intervention
Indomethacin
Study Arms / Comparison Groups
Stepwise Indo
Description: Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
68
Start Date
March 2008
Primary Completion Date
March 2010
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).
Gender
All
Ages
N/A - 4 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Cathy Hammerman, MD, 9722 6666238, [email protected]
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT00616382
Organization ID
CHPDA2
Study Sponsor
Shaare Zedek Medical Center
Study Sponsor
Cathy Hammerman, MD, Principal Investigator, Shaare Zedek Medical Center
Verification Date
January 2008