Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
This study has been completed.
Sponsor:
Zekai Tahir Burak Maternity and Teaching Hospital
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01536158
First received: February 15, 2012
Last updated: December 24, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Patent Ductus Arteriosus |
Drug: Oral paracetamol Drug: Oral ibuprofen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Oral Paracetamol Versus Oral Ibuprofen Treatment |
Resource links provided by NLM:
Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:
Primary Outcome Measures:
- Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen [ Time Frame: Until discharge ] [ Designated as safety issue: Yes ]To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment
Secondary Outcome Measures:
- Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants [ Time Frame: corrected 36 weeks or until discharge ] [ Designated as safety issue: Yes ]Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.
| Enrollment: | 80 |
| Study Start Date: | February 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
|
Drug: Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
Other Name: Calpol
|
|
Active Comparator: 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.
|
Drug: 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.
Other Name: Pedifen
|
Detailed 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.
Eligibility| Ages Eligible for Study: | up to 10 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536158
Locations
| Turkey | |
| Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology | |
| Ankara, Turkey, 06110 | |
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
Investigators
| Principal Investigator: | Mehmet Yekta Oncel, MD | Zekai Tahir Burak Maternity and Teaching Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital |
| ClinicalTrials.gov Identifier: | NCT01536158 History of Changes |
| Other Study ID Numbers: | ZTB150212 |
| Study First Received: | February 15, 2012 |
| Last Updated: | December 24, 2012 |
| Health Authority: | Turkey: Ethics Committee |
Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
|
Patent Ductus Arteriosus Paracetamol Ibuprofen Preterm infant |
Additional relevant MeSH terms:
|
Ductus Arteriosus, Patent Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Acetaminophen Ibuprofen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013