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OpenTrials
Completed

NCT Number: NCT01261117

Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.

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Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06600, Turkey (Türkiye)

About this study

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

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 ibuprofen treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Birth weight below 1000 gram
  • Diagnosed patent ductus arteriosis by Echocardiographic examination

Exclusion criteria

  • Accompanied other congenital cardiac anomalies
  • Severe thrombocytopenia < 60.000
  • Severe intracranial bleeding (Grade 3-4)
  • Intestinal abnormality and necrotising enterocolitis

Treatment and study plan

oral ibuprofen

Drug

oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals

Primary outcomes

  1. Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575

    Time frame: 6 months

    To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment

Secondary outcomes

  1. Efficacy and Safety of Oral Versus Intravenous Ibuprofen

    Time frame: Results will be identified in 6 months

    Evaluation of renal tolerance and complications

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

Oral Versus Intravenous Ibuprofen Treatment

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2010
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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