Treating the Resistant Patent Ductus Arteriosus (PDA)

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 2

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Indomethacin; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT00616382

CHPDA2

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 2 days to 4 weeks old

Volunteers: Accepts 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

Stepwise Indo

Experimental group

Description:

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

Treatment:

Drug: Indomethacin

PTX

Experimental group

Description:

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

Treatment:

Drug: Pentoxifylline