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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous IV Acetaminophen | Active Comparator | Intravenous Infusion |
|
| Rectal Acetaminophen | Active Comparator | Rectal Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal Solution | Drug | Rectal acetaminophen at 15 mg/kg x 4/day for three days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ductal closure | Follow-up echocardiogram showing closed ductus arteriosus | Up to 1 week following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| PDA Ligation | Need for surgical ligation | Completion of study intervention until 40 weeks post-conception |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathy Hammerman, MD | Contact | 0508685238 | cathyh@ekmd.huji.ac.il | |
| Alona Bin-Nun, MD | Contact | 0508685757 | alonabinnun@szmc.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Cathy Hammerman, MD | Shaare Zedek Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit - Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Intravenous Infusion | Drug | 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 |
|
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Aniline Compounds |
| D000588 | Amines |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |