Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants

NCT01544972 | Unknown Phase 4

• 1 other identifier: ZTB170212
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patent Ductus Arteriosus

Keywords

Patent Ductus Arteriosus; Paracetamol; Ibuprofen; Serum levels; Preterm infant

Outcome Measures

Primary Outcomes (1)

• To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA

  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.

  up to 6 months

Study Arms (2)

Oral paracetamol

ACTIVE COMPARATOR

Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days

Drug: Oral paracetamol

Oral ibuprofen

ACTIVE COMPARATOR

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

Interventions

Oral paracetamol DRUG

Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.

Also known as: Calpol

Oral paracetamol

Oral ibuprofen DRUG

Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Also known as: Pedifen

Oral ibuprofen

Eligibility Criteria

• Age: 2 Days - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight below 1250 gram
• Diagnosed patent ductus arteriosus by Echocardiographic examination

You may not qualify if:

• Accompanied other congenital cardiac anomalies
• Severe thrombocytopenia \< 60.000
• Severe intracranial bleeding (Grade III - IV)
• Intestinal abnormality and necrotising enterocolitis

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Sadık Yurttutan, MD

  Zekai Tahir Burak Women's Health Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sadık Yurttutan, MD

CONTACT

sdkyurttutan@gmail.com

Mehmet Yekta Oncel, MD

CONTACT

dryekta@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zekai Tahir Burak Maternity and Teaching Hospital

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 6, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

TU (1)