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Paracetamol and Patent Ductus Arteriosus (PDA)

NCT ID: NCT01291654

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Brief Summary

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The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.

Detailed Description

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Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure.

Conditions

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Patent Ductus Arteriosus

Keywords

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PDA Paracetamol Indomethacin Ibuprofen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Paracetamol

Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

po Paracetamol 15 mg/kg every 6 hours x 3 days

NSAID

Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr

Group Type EXPERIMENTAL

NSAID

Intervention Type DRUG

IV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).

D5W

Intervention Type DRUG

Since the paracetamol is given q 6 hours, in order to maintain blinding of the clinical staff, a placebo (D5W) must be given intermittently between the doses of NSAID such that each infant will receive drug every 6 hours.

Interventions

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Paracetamol

po Paracetamol 15 mg/kg every 6 hours x 3 days

Intervention Type DRUG

NSAID

IV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).

Intervention Type DRUG

D5W

Since the paracetamol is given q 6 hours, in order to maintain blinding of the clinical staff, a placebo (D5W) must be given intermittently between the doses of NSAID such that each infant will receive drug every 6 hours.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus

Exclusion Criteria

* Major congenital anomalies
* Life-threatening infection
* Active NEC and/or intestinal perforation
* Recent (within the previous 24 hours) intraventricular hemorrhage Grade 3-4
* Urine output \<1 ml per kilogram per hour during the preceding 8 hours
* Serum creatinine concentration of \>1.6 mg %
* Platelet count of \<60,000 per cc.
Minimum Eligible Age

2 Days

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Cathy Hammerman

Prof. Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cathy Hammerman, MD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University Faculty of Medicine

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Cathy Hammerman, MD

Role: CONTACT

Phone: +9722666-6238

Email: [email protected]

Alona Bin-Nun, MD

Role: CONTACT

Phone: +9722666-6757

Email: [email protected]

Facility Contacts

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Cathy Hammerman, MD

Role: primary

Other Identifiers

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SZMC-Hammerman-Acamol-2011

Identifier Type: -

Identifier Source: org_study_id