Autopsy report · NCT03701074

Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus

“very slow enrollment. Only one patient enrolled. Termination by PI”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 2 years before it stopped.
• 1 participant enrolled.
• Results were posted on the registry 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

University of South Alabama

Sponsor type

University, hospital or other

Conditions

Patent Ductus Arteriosus; Preterm Infant; Bronchopulmonary Dysplasia

Interventions

Ibuprofen and acetaminophen; Ibuprofen and placebo

Participants

1

Sites

1

Countries

United States

Trials that died the same way

• Use of a Loading Dose of Vancomycin in Pediatric Dosing
  “PI leaving institution, slow enrollment” (81% match in meaning)
• Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
  “Slow enrollment of patients” (80% match in meaning)
• Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia
  “Slow enrollment; study terminated.” (77% match in meaning)
• Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection
  “termination due to futility (very slow patient enrollment)” (75% match in meaning)
• Assess Specific Kinds of Children Challenges for Neurologic Devices Study
  “Slow enrollment” (74% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.