CompletedNot Applicable

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

United States110 participantsStarted 2007-02

Plain-language summary

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.

Who can participate

Age range6 Months

SexALL

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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.

What they're measuring

Number of infants with ductus closure

Timeframe: 6 months

Trial details

NCT IDNCT01758913

SponsorTaipei Medical University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-02

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