Prophylactic CPAP for Late Preterm Infants Born by C-Section to Reduce NICU Admission
NCT07929506, Not applicable, Not yet recruiting, Indiana University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prophylactic CPAP for Late Preterm Infants Born by C-Section to Reduce NICU Admission | ClinicalTrials.gov |
| NCT number | NCT07929506 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Indiana University | ClinicalTrials.gov |
| Conditions | Late Preterm Infant | ClinicalTrials.gov |
| Interventions | Prophylactic CPAP, Standard of Care | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of NICU admissions for respiratory support. | 60 minutes after birth | At the single assessment at 60 minutes after birth, an infant will be classified as "yes" if they need supplemental oxygen to reach an oxygen saturation greater than 92%, or need CPAP, or need mechanical ventilation. An infant will be classified as "no" if none of these criteria are met. Classification is based on need for respiratory support, regardless of the infant's actual location. | ClinicalTrials.gov |
| Secondary | Respiratory Support at 30 minutes and 24 hours after birth | 30 minutes and 24 hours after birth | An infant will be classified as "yes" if they need supplemental oxygen to reach an oxygen saturation greater than 92%, or need CPAP, or need mechanical ventilation. An infant will be classified as "no" if none of these criteria are met. Classification is based on need for respiratory support, regardless of the infant's actual location. | ClinicalTrials.gov |
| Secondary | PSS:NICU Overall Stress Level score | at hospital discharge (single measurement) | Parents will complete the PSS:NICU at infant hospital discharge to rate stress related to the NICU experience. Items are scored from 1 (not at all stressful) to 5 (extremely stressful). Using Metric 2, responses marked "not experienced" are scored as 1. For each parent, the overall score will be the mean across all PSS:NICU items (range: 1-5; maximum: 5). Mean scores and standard deviations will be reported and compared between the prophylactic CPAP and standard-care groups. Higher scores indicate greater parental stress. | ClinicalTrials.gov |
| Other | Any breastfeeding at infant hospital discharge | at hospital discharge or 30 days whichever comes first (single assessment) | At hospital discharge, the infant will be classified as "Yes" if they received any breast milk, either directly at the breast or as expressed breast milk, including in combination with formula. The infant will be classified as "No" if they received no breast milk. The number and percentage classified as "Yes" and "No" will be reported by study group | 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 3
The papers the trial lists on ClinicalTrials.gov.
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)