A Phase 2/3 interventional study of Rectal Solution and Intravenous Infusion in Ductus Arteriosus, Patent, sponsored by Shaare Zedek Medical Center. Status unknown at 1 site in Israel. Open to participants aged 2 Days to 10 Days. Per ClinicalTrials.gov, last updated 2018-07-30.
Sponsored by Shaare Zedek Medical Center · Phase 2/3, Interventional, and Treatment
Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.
Once parental consent for entrance into the study is obtained, eligible babies will be randomized to receive either IV acetaminophen (perfalgen) by continuous infusion at 2.5 mg/kg/h following a loading dose of 15 mg /kg/ over 20 minutes or rectal acetaminophen at 15 mg/kg every 6 hours for a period of 3 days.
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 81 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →Shaare Zedek Medical Center is the lead sponsor of 191 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inborn preterm neonates, \< 1000 gm birth weight; \< 28 weeks' gestational age; who are admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and are diagnosed with a hemodynamically significant patent ductus arteriosus within the first week of life and who are on limited or no enteral feeds -
Exclusion Criteria:
Other congenital heart disease, major congenital anomalies, sepsis; and/or NEC.
Intravenous Infusion
Drug: Intravenous Infusion
Rectal Solution
Drug: Rectal Solution
Rectal acetaminophen at 15 mg/kg x 4/day for three days
Also known as: acetaminophen / paracetamol
Loading dose of 15 mg/kg IV acetaminophen followed by a continuous infusion at a rate of 2.5 mg/kg/hr for 72 hours
Also known as: acetaminophen / paracetamol
Ductal closure
Follow-up echocardiogram showing closed ductus arteriosus
Time frame: Up to 1 week following treatment
PDA Ligation
Need for surgical ligation
Time frame: Completion of study intervention until 40 weeks post-conception
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Shaare Zedek Medical Center