Trial · NCT01958320
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
NCT01958320, Phase 2, Completed, University of California, San Francisco; results first posted 2018-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus. Trials, record NCT01958320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01958320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
- NCT number
- NCT01958320
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 202 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Patent Ductus Arteriosus, Surgery, Necrotizing Enterocolitis, Intestinal Perforation
- Interventions
- pharmacologic treatment of the PDA, no pharmacologic treatment of the PDA, NSAID
- First posted
- 2013-10-09
- Last updated
- 2018-11-30
- Results first posted
- 2018-11-30
- Limitations and caveats
- See detailed limitations in published manuscript
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Gavage Feeding Assistance | up to 20 weeks of age | days | MEDIAN | |
| SECONDARY | Incidence of Necrotizing Enterocolitis or Spontaneous Perforation | through hospital discharge (approximately 6 months unless death occurs first) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | the Average Daily Weight Gain | up to 20 weeks of age | gm/kg/day | MEAN | |
| SECONDARY | Incidence of Bronchopulmonary Dysplasia or Death | determined between 36-37 weeks corrected age | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Death | through hospital discharge (approximately 6 months unless death occurs first) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | the Incidence of Persistent Moderate-to-large PDA Shunt 10 Days After Enrollment | 10 days after enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | the Incidence of Rescue Treatment Eligibility Criteria Met | through hospital discharge (approximately 6 months unless death occurs first) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Infants Receiving ≥ 14 Days of Diuretic Treatment | through hospital discharge (approximately 6 months unless death occurs first) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Infants Who Received Dopamine for ≥3 Days | through hospital discharge (approximately 6 months unless death occurs first) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Early Treatment | 33 | Participants | ||
| 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) | Conservative Treatment | 38 | Participants | ||
| Duration of Gavage Feeding Assistance | Early Treatment | 76 | Inter-Quartile Range 66 to 104 | days | |
| Duration of Gavage Feeding Assistance | Conservative Treatment | 80 | Inter-Quartile Range 61 to 97 | days | |
| Incidence of Necrotizing Enterocolitis or Spontaneous Perforation | Early Treatment | 17 | Participants | ||
| Incidence of Necrotizing Enterocolitis or Spontaneous Perforation | Conservative Treatment | 19 | Participants | ||
| the Average Daily Weight Gain | Early Treatment | 22.5 | Standard Deviation 4.8 | gm/kg/day | |
| the Average Daily Weight Gain | Conservative Treatment | 22.8 | Standard Deviation 4.6 | gm/kg/day | |
| Incidence of Bronchopulmonary Dysplasia or Death | Early Treatment | 60 | Participants | ||
| Incidence of Bronchopulmonary Dysplasia or Death | Conservative Treatment | 56 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Early Treatment | 104 | |
| Overall Study | STARTED | Conservative Treatment | 98 | |
| Overall Study | COMPLETED | Early Treatment | 104 | |
| Overall Study | COMPLETED | Conservative Treatment | 98 | |
| Overall Study | NOT COMPLETED | Early Treatment | 0 | |
| Overall Study | NOT COMPLETED | Conservative Treatment | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | necrotizing enterocolitis | Gastrointestinal disorders | Early Treatment | 17 | 104 | |
| serious | necrotizing enterocolitis | Gastrointestinal disorders | Conservative Treatment | 19 | 98 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Early Treatment | 20 | 104 |
| Total, all-cause mortality | Conservative Treatment | 10 | 98 |
| Total, other adverse events | Early Treatment | 0 | 0 |
| Total, other adverse events | Conservative Treatment | 0 | 0 |
| Total, serious adverse events | Early Treatment | 17 | 104 |
| Total, serious adverse events | Conservative Treatment | 19 | 98 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Early Treatment vs Conservative Treatment: Incidence of Necrotizing Enterocolitis or Spontaneous Perforation | Trial comparisons |
| Early Treatment vs Conservative Treatment: the Incidence of Persistent Moderate-to-large PDA Shunt 10 Days After Enrollment | Trial comparisons |
| Early Treatment vs Conservative Treatment: Incidence of Bacteremia | Trial comparisons |
| Early Treatment vs Conservative Treatment: the Incidence of Rescue Treatment Eligibility Criteria Met | Trial comparisons |
| Early Treatment vs Conservative Treatment: Incidence of Pulmonary Hemorrhage | Trial comparisons |
| Early Treatment vs Conservative Treatment: Incidence of Death | Trial comparisons |
| Early Treatment vs Conservative Treatment: Number of Infants Who Received Dopamine for ≥3 Days | Trial comparisons |
| Early Treatment vs Conservative Treatment: Number of Infants Receiving ≥ 14 Days of Diuretic Treatment | Trial comparisons |
| Early Treatment vs Conservative Treatment: Incidence of Bronchopulmonary Dysplasia or Death | Trial comparisons |
| Early Treatment vs Conservative Treatment: deaths from any cause | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01958320
GET https://conductscience.org/api/trials/v1/NCT01958320/results?page=2