Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
Patent Ductus Arteriosus, Preterm Infant, Bronchopulmonary Dysplasia
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring patent ductus arteriosus, acetaminophen, ibuprofen, bronchopulmonary dysplasia, mechanical ventilation
Eligibility Criteria
Inclusion Criteria:
- Preterm infant ≤27 6/7
- Written parental consent is obtained
- Infant requires respiratory support
diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following:
- Ductus size ≥ 1.5 mm
- Maximum flow velocity through the ductus ≤ 2 m/s
- Left atrium to aorta ratio ≥ 1.4
- Wide pulse pressure
- B-type natriuretic peptide (BNP)
- Attending neonatologist made decision to treat patent ductus arteriosus
Exclusion Criteria:
- No parental consent
- Infants > 21days of postnatal age
- Congenital anomalies such as cardiac or multiple anomalies
- Infection (e.g., septicemia, pneumonia)
- Bleeding disorder or platelet count< 50,000/ml
- Acute kidney injury (AKI)defined as oliguria (urine output< 0.5 ml/kg/hr for 16hrs) and/or serum creatinine > 1.5 mg/dl
- Elevated liver enzymes (>2 fold from upper normal limits)
- Pulmonary hypertension or right to left shunt through the ductus arteriosus
- Diagnosis of necrotizing enterocolitis
- Unable to tolerate oral medications at the time of enrollment.
Sites / Locations
- University of South Alabama
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ibuprofen and acetaminophen arm (intervention arm)
ibuprofen and placebo arm (control arm)
ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses).
ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.