Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial

Patent Ductus Arteriosus Clinical Trial

Official title:

Oral Paracetamol Versus Oral Ibuprofen Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536158
• Other study ID #: ZTB150212
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2012
• Last updated: December 24, 2012
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

Description:

To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours.

One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

Inclusion Criteria:

• Birth weight below 1250 gram

• Diagnosed patent ductus arteriosus by Echocardiographic examination

Exclusion Criteria:

• Accompanied other congenital cardiac anomalies

• Urine output of less than 1 ml/kg/h during the preceding 8 h,

• Serum creatinine level >1.6 mg/dl,

• Platelet count <60,000/mm3,

• Liver failure,

• Hyperbilirubinemia requiring exchange transfusion

• Severe intracranial bleeding (Grade III - IV)

• Intestinal abnormality and necrotising enterocolitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
• Oral ibuprofen
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen	To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment	Until discharge	Yes
Secondary	Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants	Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.	corrected 36 weeks or until discharge	Yes

External Links

•   Ibuprofen
•   Paracetamol