Clinical trial NCT06601114: The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates
Official title: The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patent Ductus Arteriosus in Preterm Infants
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 254
Sex: ALL
Minimum age (years): 48
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to find and compare the effectiveness of paracetamol and ibuprofen in the closure of patent ductus arteriosus in preterm neonates.

The study is being conducted at Department of Nursery (special care baby unit) and Neonatal intensive care unit (NICU), KTH, Peshawar.

Neonates diagnosed with patent ductus arteriosus (PDA) in the Special care baby unit (SCBU) and Neonatal Intensive Care Unit (NICU) were enrolled in the study after obtaining ethical approval and informed consent from caretakers. The babies received routine care according to departmental policies. For PDA management, participants were randomly assigned to Group A, receiving oral paracetamol (Panadol, 15 mg/kg every 6 hours for 3 days), or Group B, receiving oral ibuprofen (Brufen, 10 mg/kg followed by 5 mg/kg after 24 and 48 hours). Paracetamol was defined as a selective COX-2 inhibitor, while ibuprofen was a non-selective COX inhibitor, both working by inhibiting prostaglandin synthesis. Procedures were supervised by a consultant pediatrician, with continuous patient monitoring. Treatment effectiveness, defined as complete PDA closure on echocardiography, was assessed at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Neonates of gestational age more than 30 weeks and less than 37 weeks
* Neonates with birthweight of ≥1250g
* Neonates with postnatal age of 48-96 hours
* Neonates having one of the following echocardiographic criteria: a duct size \&gt; 2mm, a left atrium-to-aorta ratio \&gt;1.4, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition to clinical signs of patent ductus arteriosus

Exclusion Criteria:

* Gestational age less than 30 weeks and more than 37 weeks
* Presence of major congenital abnormalities
* Right-to-left ductal shunting
* Life-threatening infection
* Grade III or grade IV intraventricular hemorrhage
* Platelet count of \&lt;60000/mm3
* Hyperbilirubinemia requiring blood transfusion
* Persistent pulmonary hypertension

Primary outcomes:
measure: Closure of Patent Ductus Arteriosus
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: MTI, Khyber Teaching Hospital
state: Khyber Pakhtunkhwa
Study officials:
References:
citation: Ohlsson A, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low-birth-weight infants. Cochrane Database Syst Rev. 2015 Mar 11;(3):CD010061. doi: 10.1002/14651858.CD010061.pub2.
citation: Slaughter JL, Reagan PB, Newman TB, Klebanoff MA. Comparative Effectiveness of Nonsteroidal Anti-inflammatory Drug Treatment vs No Treatment for Patent Ductus Arteriosus in Preterm Infants. JAMA Pediatr. 2017 Mar 6;171(3):e164354. doi: 10.1001/jamapediatrics.2016.4354. Epub 2017 Mar 6.
citation: Al-Lawama M, Alammori I, Abdelghani T, Badran E. Oral paracetamol versus oral ibuprofen for treatment of patent ductus arteriosus. J Int Med Res. 2018 Feb;46(2):811-818. doi: 10.1177/0300060517722698. Epub 2017 Sep 14.