Patent Ductus Arteriosus
Conditions
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 rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.
Interventions
The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.
DRUGIntravenous Ibuprofen + Oral Acetaminophen
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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 28 Weeks
Healthy volunteers
No
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: 1. Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA 2. 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) 3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination) * Echocardiographic criteria: 1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery \> 0.5
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of infants with PDA closure. | During hospitalization, up to 10 days | Percentage of patients who demonstrated PDA closure. |
Outcome results
None listed