nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
NCT07923604, Not applicable, Not yet recruiting, University Hospital, Geneva
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks | ClinicalTrials.gov |
| NCT number | NCT07923604 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 25 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Geneva | ClinicalTrials.gov |
| Conditions | Apnea of Prematurity | ClinicalTrials.gov |
| Interventions | nCPAP-NAVA-backup mode, nCPAP mode | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of severe apnea episodes per 9-hour observation period | Per 9-hour observation period | Number of severe apnea episodes per 9-hour observation period, defined as an apnea associated with oxygen desaturation (SpO₂ \< 85%) lasting ≥ 5 seconds and/or bradycardia (Heart rate (HR) \< 100 bpm) lasting ≥ 5 seconds | ClinicalTrials.gov |
| Secondary | Number of isolated oxygen desaturation episodes | Per 9-hour observation period | SpO₂ \< 85% for ≥ 5 seconds, not associated with a severe apnea episode | ClinicalTrials.gov |
| Secondary | Number of isolated bradycardia episodes | per 9-hour observation period | HR \< 100 bpm for ≥ 5 seconds, not associated with a severe apnea episode | ClinicalTrials.gov |
| Secondary | Number of hyperoxia episodes (SpO₂ > 94% for ≥ 5 seconds) | per 9-hour observation period | ClinicalTrials.gov | |
| Secondary | Percentage of time spent with SpO₂ < 85% | per 9-hour observation period | ClinicalTrials.gov | |
| Secondary | Percentage of time spent with SpO₂ > 94% | per 9-hour observation period | ClinicalTrials.gov | |
| Secondary | Percentage of time spent with HR < 100 bpm | per 9-hour observation period | ClinicalTrials.gov | |
| Secondary | Number of apnea episodes requiring nurse intervention | per 9-hour observation period | tactile stimulation and/or increase in FiO₂ | ClinicalTrials.gov |
| Secondary | Need for escalation of respiratory support during the observation period | per 9-hour observation period | Defined as requirement for transition to non-invasive ventilation mode or endotracheal intubation | ClinicalTrials.gov |
| Secondary | Infant comfort assessed using the EDIN score (Échelle Douleur Inconfort Nouveau-Né) | per 9-hour observation period | EDIN will be recorded every 3 hours (0-15), yielding up to 3 measurements per 9-hour observation period. The mean EDIN score over each observation period will be used | ClinicalTrials.gov |
| Secondary | Gastrointestinal tolerance | per 9-hour observation period | Grade 1: good tolerance - enteral feeding maintained at prescribed volume with no significant gastric residuals ; Grade 2: moderate intolerance - enteral feeding volume reduced due to gastric residuals or clinical concern ;Grade 3: poor tolerance - enteral feeding discontinued with initiation of continuous gastric suctioning. The worst grade recorded during each 9-hour observation period will be used as the summary measure for analysis. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)