Trial · NCT07216365
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Oxygen Saturation Index (OSI) per Patient Over First 56 Days | From Randomization to Day 56 or Caffeine Discontinuation | The OSI is calculated as (FiO₂ × MAP × 100) / SpO₂. The average OSI per patient will be calculated from randomization through the first 56 days or until caffeine is discontinued or the patient is discharged. Higher OSI values indicate worse oxygenation. |
| Primary | Total Duration of Respiratory Support | From Randomization to 1 year | Total number of days each patient receives any respiratory support, including invasive ventilation, CPAP, or supplemental oxygen. |
| Primary | Total Incidence of Severe Bronchopulmonary Dysplasia (BPD) | From Randomization to 1 year | Number of infants diagnosed with severe BPD based on NICHD criteria. |
| Primary | Total Incidence of Severe Intraventricular Hemorrhage or Periventricular Leukomalacia (IVH/PVL) | From Randomization to 1 year | Number of infants diagnosed with severe IVH (Grade III/IV) or PVL based on cranial imaging. |
| Primary | Total Length of NICU Stay | Birth to 1 year | Total number of days each infant remains in the NICU from birth until discharge. |
| Primary | Total Number of Infant Deaths | From Randomization to 1 year | Number of infants who die before NICU discharge. |
| Primary | Total Test of Infant Motor Performance (TIMP) Score Prior to Discharge | Prior to NICU Discharge | TIMP is a 42-item motor development assessment. Each item scores from 0 to 6. Total scores range from 0 to 252. Higher scores indicate better motor performance. |
| Primary | Total Duration of SpO₂ Below Threshold (Intermittent Hypoxia) | From Randomization through Day 56 | Cumulative minutes with SpO₂ below target threshold, derived from Neo-DReAMS repository. |
| Primary | Total Time with Heart Rate >180 bpm (Tachycardia) | From Randomization to 1 year | Total minutes with heart rate exceeding 180 bpm recorded via monitor. |
| Primary | Total Growth Parameter Z-Scores (Length, Weight, Head Circumference) | From Randomization to 1 year | Growth will be assessed using Fenton z-scores. Higher scores reflect better growth relative to gestational norms. |
| Primary | Total Osteopenia Markers (Alkaline Phosphatase, Calcium, Phosphorus) | From Randomization to 1 year | Osteopenia assessed by abnormal lab values: alkaline phosphatase \>500 IU/L, abnormal calcium or phosphorus. Abnormal values per infant will be summed. |
| Primary | Total Incidence of Hypertension (>95th Percentile) | From Randomization to 1 year | Number of days with blood pressure \>95th percentile for gestational age. |
| Primary | Total Time to Full Enteral Feeds | From Randomization to 1 year | Days from birth until the infant reaches 120 mL/kg/day enteral nutrition. |
| Primary | Total Number of NPO Periods >24 Hours | From Randomization through NICU Discharge | Number of times infant is NPO (nothing by mouth) for more than 24 hours. |
| Primary | Total Incidence of Necrotizing Enterocolitis (NEC) | From Randomization to 1 year | Number of infants diagnosed with NEC (Bell's stage II or higher). |
| Primary | Total Incidence of Spontaneous Intestinal Perforation (SIP) | From Randomization to 1 year | Number of infants with radiographically or surgically confirmed SIP. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07216365/registered