Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants
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Purpose
The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels 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: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen |
- To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
The measurement of Serum levels of Paracetamol and Ibuprofen in preterm infants treated with Oral Paracetamol and Oral Ibuprofen.
To determine of effective serum levels of paracetamol and ibuprofen for treatment of patent ductus arteriosus in preterm infants.
In normally, effective and safely dose of NSAIDs for treatment of PDA are exactly unknown. Therefore we will detected cut-off serum levels for effective, safely and hazardous.
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 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 for 3 days
|
Drug: Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
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 oral paracetamol and ibuprofen efficacy and safety in relation to serum levels 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 for 3 days.
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.
Three consecutive blood sample from infants for 3 days before dose application of drugs(ibuprofen and paracetamol will be obtained.
The relation of pharmacokinetics of drugs to drug response will be evaluated
Eligibility| Ages Eligible for Study: | up to 10 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Birth weight below 1250 gram
- Diagnosed patent ductus arteriosus by Echocardiographic examination
Exclusion Criteria:
- Accompanied other congenital cardiac anomalies
- Severe thrombocytopenia < 60.000
- Severe intracranial bleeding (Grade III - IV)
- Intestinal abnormality and necrotising enterocolitis
Contacts and Locations| Contact: Sadık Yurttutan, MD | sdkyurttutan@gmail.com | |
| Contact: Mehmet Yekta Oncel, MD | dryekta@gmail.com |
| Turkey | |
| Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology | Recruiting |
| Ankara, Turkey | |
| Contact: Ugur Dilmen, Professor ugurdilmen@gmail.com | |
| Contact: Omer Erdeve, As.Prof omererdeve@yahoo.com | |
| Principal Investigator: Sadık Yurttutan, MD | |
| Principal Investigator: | Sadık Yurttutan, MD | Zekai Tahir Burak Maternity and Teaching Hospital |
More Information
No publications provided
| Responsible Party: | Sadik Yurttutan, Zekai Tahir Burak Maternity and Teaching Hospital |
| ClinicalTrials.gov Identifier: | NCT01544972 History of Changes |
| Other Study ID Numbers: | ZTB170212 |
| Study First Received: | February 22, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | Turkey: Ethics Committee |
Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
|
Patent Ductus Arteriosus Paracetamol Ibuprofen Serum levels 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 21, 2013