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

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Brief Title

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

Official 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

Brief 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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Number of infants with ductus closure

Secondary Outcome

 Urine output

Condition

Patent Ductus Arteriosus

Intervention

Ibuprofen

Study Arms / Comparison Groups

 Ibuprofen
Description:  Infant who was assigned to ibuprofen, an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours respectively as a course was given.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

110

Start Date

February 2007

Completion Date

February 2012

Primary Completion Date

February 2012

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 6 Months

Accepts Healthy Volunteers

No

Contacts

Tsu-Fu Yeh, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01758913

Organization ID

PDA Ind Ibu ELBW


Responsible Party

Sponsor

Study Sponsor

Taipei Medical University Hospital

Collaborators

 John H. Stroger Hospital

Study Sponsor

Tsu-Fu Yeh, MD, PhD, Principal Investigator, Taipei Medical University


Verification Date

December 2012