Clinical trial NCT00616382: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Patent Ductus Arteriosus
Keywords: PDA
indomethacin
pentoxifylline
Patent Ductus Arteriosus [PDA] resistant to therapy
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols.
timeFrame: 2 years
measure: To monitor and compare potential side effects of the two treatment approaches
timeFrame: 2 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Neonatal Intensive Care Unit - Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Cathy Hammerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.