Paracetamol Versus Ibuprofen for PDA Closure

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03265782

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Drug: ibuprofen Drug: paracetamol	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants

Actual Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2017

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ibuprofen group 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	Drug: ibuprofen drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days Other Names: brufen
Experimental: paracetamol group 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	Drug: paracetamol drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days Other Names: cetal

Arm

Intervention/Treatment

Experimental: ibuprofen group

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

Drug: ibuprofen

drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days

Other Names:

brufen

Experimental: paracetamol group

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

Drug: paracetamol

drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days

Other Names:

cetal

Outcome Measures

Primary Outcome Measures

closure of PDA [6 days]
Echo confirmed closure

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Weeks to 35 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Gestational age ≤ 35 weeks
Aged 2-7 days with color Doppler echocardiographic evidence of PDA
Urine output more than 1 ml/kg/hr
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:

Congenital heart diseases of any type including

Pulmonary stenosis
Anomalus in pulmonary venous drainage
Ventricular septal defect

Major congenital anomalies as hydrops fetalis
Low platelets count (less than 60, 000/mm3)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rania Ali El-Farrash, pricipal investigator, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03265782

Other Study ID Numbers:

43214321

First Posted:

Aug 29, 2017

Last Update Posted:

Aug 29, 2017

Last Verified:

Aug 1, 2017

Keywords provided by Rania Ali El-Farrash, pricipal investigator, Ain Shams University

Additional relevant MeSH terms:

Ductus Arteriosus, Patent

Acetaminophen

Ibuprofen

Study Results

No Results Posted as of Aug 29, 2017