Trial · NCT03701074
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Ductus Arteriosus Closure/Constriction | 24-48 hours after the completion of study intervention | Ductal closure/constriction rate as defined based on the echocardiographic findings. Ductal closure/constriction will be defined as the complete closure of ductus or ductal diameter \<1 mm |
| Secondary | Echocardiographic Patent Ductus Arteriosus Parameters Before and After the Study Intervention | 24-48 hours after the completion of study intervention | Echocardiographic parameters including ductal size (PDA size in mm), Left atrium to aortic root ratio, ductal velocity, descending aortic diastolic flow, before and after the intervention. Between the group and within the group comparison |
| Secondary | Ventilatory Settings Before and After the Study Intervention | 24-48 hours after the completion of study intervention | Ventilator parameters including Fio2, Mean airway pressure, Peak Inspiratory pressure, PEEP, and ventilatory rate oxygenation indices including Oxygenation index and Respiratory Severity score before and after intervention |
| Secondary | Proportion of Participants With Liver Injury | 24-48 hours after the completion of study intervention | liver enzymes compared before and after the study intervention; if any significant elevation of liver enzymes from baseline, the participant classified as having liver injury |
| Secondary | Proportion of Participants With Renal Injury | 24-48 hours after the completion of study intervention | Blood urea nitrogen (BUN) and serum creatinine before and after the study intervention are compared. Participants exhibiting significant elevation BUN and S creatine, are classified as having renal injury |
| Secondary | Proportion of Participants With Hematological Adverse Events | 24-48 hours after the completion of study intervention | Hematocrit and platelet counts compared before and after the study intervention; if any significant alteration from baseline, the participant classified as having hematological adverse event, |
| Secondary | Total Number of Days of Mechanical Ventilation | from randomization until discharge/40 weeks post menstrual age | The total number of days on mechanical ventilation are counted as total duration of conventional mechanical ventilation plus high frequency ventilatory days |
| Secondary | Total Number of Days of Need for Supplemental Oxygen | from randomization until discharge/40 weeks post menstrual age | Cumulative days on any supplemental O2 (including Mechanical ventilation., noninvasive ventilation, nasal cannula support) calculated from randomization until 4 weeks of postmenstrual age |
| Secondary | Duration of Noninvasive Ventilation | from randomization until discharge/40 weeks post menstrual age | Total cumulative days on noninvasive ventilation, including NIPPV and nasal CPAP, |
| Secondary | Proportion of Participants With Persistence of Ductus-needing Pharmacological Treatment | from randomization until discharge/40 weeks post menstrual age | Proportion of participants in each group requiring open label treatment with pharmacological agents for ductal closure, e.g. IV Ibuprofen or IV Acetaminophen or IV indomethacin therapies, as decided by the treating physician |
| Secondary | Proportion of Participants Requiring Surgical Ligation of PDA | from randomization until discharge/40 weeks post menstrual age | Proportion of participants in each group requiring surgical ligation of persistent PDA for definitive surgical closure |
| Secondary | Proportion of Participants Developing Bronchopulmonary Dysplasia | at 36 weeks post menstrual age | Proportion of participants diagnosed to have BPD based supplemental O2 requirement at 36 weeks' postmenstrual age |
| Secondary | Percentage of Infants Requiring Home Oxygen Therapy | at discharge/40 weeks post menstrual age | Proportion of participants in each group requiring home-based supplemental O2 therapy following the initial discharge from hospital. |
| Secondary | Proportion of Participants Developing Death Before Discharge | until discharge/40 weeks post menstrual age | Proportion of participants in each group developing in-hospital death prior to 40 weeks of postmenstrual age. |
| Secondary | Time to Achieve Full Enteral Feeding | from birth until discharge/40 weeks post menstrual age | Duration days during the postnatal period required to achieve an enteral feeding volume of 120 ml/kg/day. |
| Secondary | Total Days on Total Parenteral Nutrition | from birth until discharge/40 weeks post menstrual age | Cumulative days of receiving total parental nutrition from birth until the participant is discharged or reached postmenstrual age of 40 weeks |
| Secondary | Proportion of Participants With Retinopathy of Prematurity | from birth until discharge/40 weeks post menstrual age | Proportion of participants in each group diagnosed to have retinopathy of prematurity |
| Secondary | Proportion of Participants Developing Spontaneous Intestinal Perforation | from randomization until discharge/40 weeks post menstrual age | Proportion of participants developing or having the diagnosis of spontaneous intestinal perforation from randomization until discharge or 40 weeks' Postmenstrual age |
| Secondary | Proportion of Participants Developing Necrotizing Enterocolitis | from randomization until discharge/40 weeks post menstrual age | Proportion of participants in each group with the diagnosis of medical or surgical Necrotizing Enterocolitis |
| Secondary | Proportion of Participants Developing Gastrointestinal Hemorrhage | from randomization until discharge/40 weeks post menstrual age | Proportion of participants in each group developing gastrointestinal hemorrhage following randomization until discharge or postmenstrual age of 40 weeks |
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.
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