Trial · NCT01958320
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits) | through hospital discharge (approximately 6 months unless death occurs first) | Number of infants who undergo in hospital PDA ligations or who have an open ductus at the time of discharge (that need future outpatient cardiology follow-up visits) |
| Secondary | Duration of Gavage Feeding Assistance | up to 20 weeks of age | duration of gavage feeding assistance |
| Secondary | Incidence of Necrotizing Enterocolitis or Spontaneous Perforation | through hospital discharge (approximately 6 months unless death occurs first) | incidence of necrotizing enterocolitis or spontaneous perforation |
| Secondary | the Average Daily Weight Gain | up to 20 weeks of age | the average daily weight gain |
| Secondary | Incidence of Bronchopulmonary Dysplasia or Death | determined between 36-37 weeks corrected age | incidence of bronchopulmonary dysplasia or death |
| Secondary | Incidence of Death | through hospital discharge (approximately 6 months unless death occurs first) | incidence of death |
| Secondary | the Incidence of Persistent Moderate-to-large PDA Shunt 10 Days After Enrollment | 10 days after enrollment | the incidence of persistent moderate-to-large PDA shunt 10 days after enrollment The echocardiographic studies included two dimensional imaging, M-mode, color flow mapping and Doppler interrogation as previously described. A moderate-to-large PDA was defined by a ductus internal diameter ≥ 1.5mm (or PDA:left pulmonary artery diameter ratio ≥0.5) and one or more of the following echocardiographic criteria: a) left atrium-to-aortic root (LA/Ao) ratio ≥1.6, b) ductus flow velocity ≤2.5m/sec or mean pressure gradient across the ductus ≤8mm, c) left pulmonary artery diastolic flow velocity \> 0.2 m/sec, and/or d) reversed diastolic flow in the descending aorta. Ductus that failed to meet these criteria were considered to be "constricted" (small or closed) and not eligible for enrollment or treatment. |
| Secondary | the Incidence of Rescue Treatment Eligibility Criteria Met | through hospital discharge (approximately 6 months unless death occurs first) | Infants were eligible for rescue PDA drug treatment if they met one or more of the following prespecified "Rescue" criteria: 1) Inotrope-dependent hypotension for at least 3 days. 2) Oliguria that persisted for at least 2 days with no obvious cause, other than the moderate PDA, to explain the condition. 3) Requirement for gavage feedings beyond 35 weeks corrected age due to increased work of breathing. 4) Respiratory support needed after the following postnatal ages that surpassed specific minimal ventilation and FiO2 requirements: \>15 days (if still required intubation and FiO2 \>0.30), \>20 days (if still required intubation and FiO2 ≤0.30; or still required Nasal CPAP or Nasal ventilation and FiO2 \>0.30), \>30 days (if still required Nasal CPAP or Nasal ventilation and FiO2 0.25-0.30), and \>45 days (if still required Nasal CPAP or Nasal ventilation and FiO2 \<0.25). |
| Secondary | Number of Infants Receiving ≥ 14 Days of Diuretic Treatment | through hospital discharge (approximately 6 months unless death occurs first) | number of infants receiving ≥ 14 days of diuretic treatment |
| Other | Number of Infants Who Received Dopamine for ≥3 Days | through hospital discharge (approximately 6 months unless death occurs first) | number of infants who received dopamine for ≥3 days |
| Other | Incidence of Bacteremia | through hospital discharge (approximately 6 months unless death occurs first) | incidence of bacteremia |
| Other | Incidence of Pulmonary Hemorrhage | through hospital discharge (approximately 6 months unless death occurs first) | incidence of pulmonary hemorrhage |
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/NCT01958320/registered