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Unable to obtain funding to support this project
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Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen+Acetaminophen Group | Active Comparator | Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses). |
|
| Ibuprofen Group | Placebo Comparator | Infants with PDA randomized to the control mono therapy group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Ibuprofen | Drug | The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of infants with PDA closure. | Percentage of patients who demonstrated PDA closure. | During hospitalization, up to 10 days |
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Inclusion Criteria:
Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams
Hemodynamically significant PDA as defined by any of the following:
Echocardiographic criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanket D Shah, MD | University of Florida | Principal Investigator |
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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 |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Intravenous Ibuprofen + Oral Acetaminophen | Drug | The combined treatment group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently and will in addition receive 15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses. |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Aniline Compounds |
| D000588 | Amines |