Paracetamol Versus Ibuprofen for PDA Closure

Ain Shams University

Status and phase: Unknown; Phase 4

Conditions: Patent Ductus Arteriosus

Treatments: Drug: paracetamol; Drug: ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT03265782

43214321

Details and patient eligibility

About

Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants

Full description

A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct.

Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.

Enrollment: 30 patients

Sex: All

Ages: 28 to 35 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gestational age ≤ 35 weeks
2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA
3. Urine output more than 1 ml/kg/hr
4. Creatinine concentration level less than 1.8 mg/dl

Exclusion criteria

Neonates who have one or more of the following criteria were excluded from the study:

1. Congenital heart diseases of any type including

   • Pulmonary stenosis
   • Anomalus in pulmonary venous drainage
   • Ventricular septal defect

2. Major congenital anomalies as hydrops fetalis

3. Low platelets count (less than 60, 000/mm3)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ibuprofen group

Experimental group

Description:

treatment of pda with oral ibuprofen with a loading dose 10 mg/kg/ds in the first day followed by 5 mg/kg/ds in the second ant third days then a follow up echo is done

Treatment:

Drug: ibuprofen

paracetamol group

Experimental group

Description:

treatment of pda with oral paracetamol with dose of 15 mg/kg/ds every 6 hours for 3 days then a follow up echo is done

Treatment:

Drug: paracetamol