Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601114
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkg every 6 hours for 3 days or Group B receiving oral ibuprofen Brufen 10 mgkg followed by 5 mgkg 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
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 mgkg every 6 hours for 3 days or Group B receiving oral ibuprofen Brufen 10 mgkg followed by 5 mgkg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None