Trial · NCT07216365
Caffeine Optimization for Oxygen Saturation Index in ELBW Infants
NCT07216365, Phase 2, Recruiting, University of Rochester
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Caffeine Optimization for Oxygen Saturation Index in ELBW Infants. Trials, record NCT07216365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07216365
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caffeine Optimization for Oxygen Saturation Index in ELBW Infants
- NCT number
- NCT07216365
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- University of Rochester
- Conditions
- Neonatal Apnea, Infants
- Interventions
- Caffeine Citrate
- First posted
- 2025-10-14
- Last updated
- 2026-07-29
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
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/NCT07216365
GET https://conductscience.org/api/trials/v1/NCT07216365/registered