Clinical trial NCT01070745: Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)
Official title: Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Patent Ductus Arteriosus
Keywords: PDA
Indomethacin
Ibuprofen
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation, however persistence of ductal patency postnatally may have significant adverse hemodynamic effects in the neonate. Medical therapy for PDA predominantly involves the administration of one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these therapies have been shown to be successful in mediating ductal closure in approximately 70% of treated infants.

However, the need for a second course of treatment for PDA closure remains quite common. The investigators hypothesize that, because of small differences between the two drugs, a greater percentage of infants who did not respond to a first course of therapy with indomethacin will respond to a second course with ibuprofen than to a repeat course of indomethacin.

As such, the investigators aim to compare secondary therapy with a repeat course of indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent after a first course of therapy with indomethacin.


Eligibility criteria: Inclusion Criteria:

* Inborn premature neonates (birth weight \[BW\] \<1500 grams) being treated in the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as still having a hemodynamically significant patent ductus arteriosus (hsPDA) after a first course of therapy with indomethacin, will be considered as potential candidates for study pending response to initial therapy and pending parental consent.

Exclusion Criteria:

* Any baby not considered viable
* Any baby with intraventricular hemorrhage (IVH) grade 3-4 of recent onset (within 3 days). \[If no head ultrasound has been performed within the last 3-4 days, one should be performed prior to onset of study.\]
* 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: Improvement in ductal closure rates in those infants who do not respond to a first course of therapy
timeFrame: 2.5 years
Secondary outcomes:
measure: More infants who did not respond to a first course of therapy with indomethacin who respond to a second course with ibuprofen than to a repeat course of indomethacin
timeFrame: 2.5 years
measure: Secondary treatment with ibuprofen, as opposed to indomethacin, will not be associated with increased side effects
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Investigator
name: Cathy Hammerman, MD
role: PRINCIPAL_INVESTIGATOR
References: