Trial · NCT01994993
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Death | Within 30 days after last dose of study drug, up to 40 days | Number of Participants who experienced Death |
| Secondary | Number of Participants With Therapeutic Success at Day 30 | 30 days after last dose of study drug | Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score \>4. Clinical cure score =1 for each of the following elements: FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment |
| Other | Number of Participants With Feeding Intolerance | 90 days after last dose of study drug | Feeding intolerance confirmed by documentation of any feedings held for \>24 consecutive hours in infants being fed |
| Other | Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH) | 90 days after last dose of study drug | Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement Grade 4 IVH: Intraparenchymal hemorrhage |
| Other | Number of Participants With Short Bowel Syndrome | 90 days after last dose of study drug | Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve. Total parenteral nutrition for \>42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age |
| Other | Number of Participants With Intestinal Perforation | 90 days after last dose of study drug | Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis. Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement |
| Other | Number of Participants With Intestinal Stricture | 90 days after last dose of study drug | Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis. Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement |
| Other | Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection | 90 days after last dose of study drug | Progression is determined by the clinical NEC scoring |
| Other | Number of Participants With Gastrointestinal Surgeries | 90 days after last dose of study drug | Determined by medical history and confirmed with hospital records. (Laparotomy) |
| Other | Number of Participants With Seizure | 90 days after last dose of study drug | documented seizure(s) in hospital records |
| Other | Number of Participants With Positive Blood Cultures | 90 days after last dose of study drug | Positive blood culture (bacterial or fungal) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01994993/registered