Acetaminophen vs Indomethacin in Treating hsPDA (NCT03537144) | Clinical Trial Compass
TerminatedPhase 3
Acetaminophen vs Indomethacin in Treating hsPDA
Stopped: Difficulty enrolling patients
United States37 participantsStarted 2016-06
Plain-language summary
The purpose of this study is to see if acetaminophen (Tylenol) is as effective as indomethacin in closing patent ductus arteriosus in premature infants.
Who can participate
Age range22 Weeks – 32 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Gestational age at birth 22 weeks to 31 6/7 weeks.
* Birth weight ≤ 1500 grams
* Day of life ≤ 21 days
* ECHO findings:
Left-to-right ductal flow AND 2 of the following 3:
* Ductal size \> 1.5mm at smallest diameter
* Reversal of flow in descending aorta
* Left atrial size to aortic root ratio \>1.5
* Platelet count \> 50,000
Exclusion Criteria:
* Ductal dependent congenital heart disease
* Major congenital anomaly
* Life-threatening infection
* Urine output \< 1cc/kg/hr in prior 8 hours
* Serum creatinine \> 1.8 mg/dL
* Hyperbilirubinemia requiring exchange transfusion
* Active NEC Stage 2 or 3 using Bell's staging criteria
* Active intestinal perforation
* Liver dysfunction \[2x upper limit of normal for aspartate aminotransferase(AST) and/or alanine aminotransferase (ALT)\]
* Active GI bleeding
* Concurrent hydrocortisone use
* Known IVH Grade 3 or 4
What they're measuring
1
Successful treatment of PDA closure
Timeframe: Follow-up ECHO to assess for closure within 7 days of treatment initiation