Paracetamol and Patent Ductus Arteriosus (PDA)

NCT01291654 | Unknown Phase 2

• 1 other identifier: SZMC-Hammerman-Acamol-2011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patent Ductus Arteriosus

Keywords

PDA; Paracetamol; Indomethacin; Ibuprofen

Outcome Measures

Primary Outcomes (1)

• Closure of the Ductus

  3 days

Secondary Outcomes (2)

• Absence of peripheral vasoconstriction

  48 hours

• Absence of hepatotoxicity

  1 week

Study Arms (2)

Paracetamol

EXPERIMENTAL

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

Drug: Paracetamol

NSAID

EXPERIMENTAL

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

Drug: NSAID; Drug: D5W

Interventions

Paracetamol DRUG

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

Paracetamol

NSAID 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).

NSAID

D5W 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.

NSAID

Eligibility Criteria

• Age: 2 Days - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

RECRUITING

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Cathy Hammerman, MD

  Hebrew University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Hammerman, MD

CONTACT

+9722666-6238; cathy@cc.huji.ac.il

Alona Bin-Nun, MD

CONTACT

+9722666-6757; alona.binnun@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Pediatrics

Study Record Dates

• First Submitted: February 6, 2011
• First Posted: February 8, 2011
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

IL (1)