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NCT07390812 · ClinicalTrials.gov registry record · Early Phase 1
Respiratory Transition Without Continuous Positive Airway Pressure
A Early Phase 1 study of Mild Respiratory Distress, sponsored by Hackensack Meridian Health.
- Active
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT07390812: Active Early Phase 1 study of Mild Respiratory Distress, sponsored by Hackensack Meridian Health.
NCT07390812 is a Early Phase 1 study of Mild Respiratory Distress that is active but no longer recruiting, run by Hackensack Meridian Health. The registered enrollment target is 22 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07390812, a Early Phase 1 study of Mild Respiratory Distress, is active but no longer recruiting, sponsored by Hackensack Meridian Health.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). The secondary aim is to determine the incidence of pneumothorax (PTX) for all term neonates assessed to have mild respiratory distress in the delivery room (DR).
Primary Outcome
Babies with mild respiratory distress will be observed for 20 minutes (randomized at 5 minutes of life) using a pulse oximeter (per institutional post-resuscitation care guidelines) and under the study team's direct observation. The active cohort will not receive CPAP unless respiratory distress worsens.
Conditions Studied
Interventions
- OTHER Transition without Continuous Positive Airway Pressure (CPAP)
- OTHER CPAP
Study Locations (1)
New Jersey
- Hackensack Univeristy Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-01-11 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What the registry record for NCT07390812 still lists
NCT07390812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Mild Respiratory Distress appearing as the primary indexed condition, and to 2 interventions - of which Transition without Continuous Positive Airway Pressure (CPAP) is the first listed.
NCT07390812 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT07390812 about?
NCT07390812 is a clinical study titled "Respiratory Transition Without Continuous Positive Airway Pressure". The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). The secondary aim is to determine the incidence of pneumothorax (PTX) for all term ...
What is the current status of trial NCT07390812?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2023-01-11. Estimated completion is 2026-12.
What conditions does trial NCT07390812 study?
This clinical trial studies the following conditions: Mild Respiratory Distress.
What interventions are being tested in trial NCT07390812?
The interventions under investigation include: Transition without Continuous Positive Airway Pressure (CPAP) (OTHER), CPAP (OTHER).
Who is sponsoring clinical trial NCT07390812?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07390812 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07390812's enrollment target sits among peer trials
22 1104th of 2000 higher than 872 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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