Status:
WITHDRAWN
Addition of Acetaminophen in Standard PDA Management
Lead Sponsor:
University of Florida
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
23-28 years
Phase:
PHASE2
Brief Summary
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 rate...
Eligibility Criteria
Inclusion
- 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:
- Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
- Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
- Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
- Echocardiographic criteria:
- Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery \> 0.5
Exclusion
- No enteral feedings
- PDA-dependent congenital heart disease
- Prior treatment with prophylactic indomethacin
- Prior PDA treatment with any medications
- Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
- Abnormal liver enzymes (ALT \> 60 IU/L and AST \> 60 IU/L)
- Platelets count \< 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
- Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
- Prior enrollment to other interventional clinical study where PDA is an outcome variable
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04026464
Start Date
April 1 2021
End Date
May 12 2021
Last Update
June 24 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.