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NCT Number: NCT01758913

Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants

Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as indomethacin but has less adverse effects on renal function, cerebral blood flow and mesenteric blood flow.1-7 There are, however, very few studies being done specifically on extremely low birth weight (ELBW) infant < 1000 g. This group of infants has immature kidney and often has poor response to PG inhibitors and has high mortality and morbidity. We hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be different between indomethacin and ibuprofen.

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Key information

About this study

The aims of this study are to compare the efficacy, the side effects and the renal prostaglandin (PG) excretion between indomethacin and ibuprofen in extremely low birth weight (ELBW) infants. We enrolled one hundred and ten ELBW infants who had clinically significant and echo-evidence patent ductus arteriosus were assigned into 2 groups, 56 received indomethacin (0.2 mg/kg, 0.1 mg/kg and 0.1 mg/kg in 24 hours interval) and 54 received ibuprofen (10 mg/kg, 5mg/kg and 5 mg/kg in 24 hours interval). Serum electrolytes, creatinine, renal function (urine output, glomerular filtration rate (GFR), fractional excretion of sodium and potassium, osmolar clearance and free water clearance), urinary PG excretion, pulmonary outcome and mortality were all evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The selection criteria were: (1) preterm infants with birth weight <1000 g; 2) radiographic diagnosis of respiratory distress syndrome (RDS); (3) requirement of mechanical ventilation and (4) echocardiographic and clinical evidence of significant patent ductus arteriosus (PDA).

Exclusion criteria

  • Exclusion criteria included: (1) evidence of infection or sepsis; 2) lethal congenital anomalies; (3) oliguria (< 1 ml/kg/h) and/or serum creatinine > 2.0 mg/dl and (4) low platelet count (< 50,000/mm3) or bleeding tendency.

Treatment and study plan

Ibuprofen

Drug

To compare the efficacy, the side effects and the renal prostaglandin (PG) excretion between indomethacin and ibuprofen in extremely low birth weight (ELBW) infants.

Other names: 2-[4-(2-methylpropyl)phenyl]propanoic acid

Primary outcomes

  1. Number of infants with ductus closure

    Time frame: 6 months

    To compare the number of infants with ductus closure treated with indomethacin and ibuprofen in extremely low birth weight infants.

Secondary outcomes

  1. Urine output

    Time frame: 1 month

    To compare the urine output between indomethacin and ibuprofen treatment in extremely low birth weight infants.

Other outcomes

  1. Serum creatinine

    Time frame: 1 month

    To compare serum creatinine between indomethacin and ibuprofen treatment in extremely low birth weight infants.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Collaborators

  • China Medical University Hospital
  • Cook County Health

Registry information

Official study title

Pharmacological Closure of Patent Ductus Arteriosus in Extreme Low Birth Weight Infants. A Comparison of Efficacy, Side Effects and Outcomes Between Indomethacin and Ibuprofen

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jan 1, 2013
Registry last updated
Jan 3, 2013

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

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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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