Comparison of the efficacy of oral Acetaminophen and oral Ibuprofen for treatment of preterm with patent ductus arteriosus

Comparison of the efficacy of oral Acetaminophen and oral Ibuprofen for treatment of preterm with patent ductus arteriosus

A clinical trial with parallel groups, single-blinded, randomized (permuted block randomization), phase 3 on 60 newborns, using www.sealedenvelope.com for randomization

This interventional study will be conducted from April to Nov 2020. A total of 60 preterm neonates with diagnosis of PDA admitted in NICU of Akbar Abadi Hospital Tehran were selected. Neonates are randomly assigned to two groups. In the first intervention group, oral Acetaminophen is given every 8 hours at a dose of 15 mg/kg for 3 days. In the second intervention group, oral Ibuprofen every 8 hours at a dose of 10 mg/kg for 3 days.

Inclusion criteria: Parent's consent to participate in the study, Gestational age 26 to 37 weeks, Diagnosis of ductus arteriosus based on echocardiographic evidence at 24 to 72 hours after birth. Exclusion criteria: Premature newborn with fever and seizure, Life-threatening infections, Clinical or radiographic evidence of necrotizing enterocolitis Evidence of bleeding, Platelets less than 50,000 per ml Liver failure , Congenital brain-neurological disorders, Metabolic and genetic syndromes, Pulmonary hypoplasia syndrome, Congenital heart anomalies or other fatal abnormalities

Total of 30 neonates in the first intervention group and 30 neonates in the second intervention group. In the first intervention group, oral Acetaminophen is taken every 8 hours at a dose of 15 mg/kg for 3 days. In the second intervention group, oral Ibuprofen is taken every 8 hours at a dose of 10 mg/kg for 3 days.

The closure of the ductus arteriosus (complete, incomplete, unchanged)

In this study, the block randomization method is used with blocks of sizes 4 , 6 and 8. The website https://www.sealedenvelope.com is used to create a randomization list. The blocks are randomly selected using this website and given to a researcher who is not involved in choosing the type of drug. Each random chain generated contains a unique code for concealment. The drug regimen is placed in envelopes according to random chains, and after sealing it on the envelopes, the specific number created by the site is written and the envelopes are randomly placed in a box. a box.

This study is single-blinded and patients are unaware of the type of medication received. How to blind patients: Acetaminophen and Ibuprofen are both taken orally and given to infants 1-3 days old with a dropper.