Paracetamol and Patent Ductus Arteriosus (PDA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01291654|
Recruitment Status : Unknown
Verified December 2012 by Cathy Hammerman, Shaare Zedek Medical Center.
Recruitment status was: Recruiting
First Posted : February 8, 2011
Last Update Posted : December 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Patent Ductus Arteriosus||Drug: Paracetamol Drug: NSAID Drug: D5W||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2014|
Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days
po Paracetamol 15 mg/kg every 6 hours x 3 days
Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr
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).
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.
- Closure of the Ductus [ Time Frame: 3 days ]
- Absence of peripheral vasoconstriction [ Time Frame: 48 hours ]Doppler flow velocity in anterior cerebral artery, superior mesenteric artery and renal artery will be measured before and after pharmacologic treatment.
- Absence of hepatotoxicity [ Time Frame: 1 week ]Liver function will be compared between the two study groups at 1 week following completion of pharmacologic treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291654
|Contact: Cathy Hammerman, MDfirstname.lastname@example.org|
|Contact: Alona Bin-Nun, MDemail@example.com|
|Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 91031|
|Contact: Cathy Hammerman, MD +9722666-6238 firstname.lastname@example.org|
|Principal Investigator: Cathy Hammerman, MD|
|Principal Investigator:||Cathy Hammerman, MD||Hebrew University Faculty of Medicine|