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NCT04413097 · ClinicalTrials.gov registry record · NA
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
A NA study of Respiratory Insufficiency and Extreme Prematurity, sponsored by Sharp HealthCare.
- Active
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 3
- Study locations
NCT04413097: Active NA study of Respiratory Insufficiency and Extreme Prematurity, sponsored by Sharp HealthCare.
NCT04413097 is a NA study of Respiratory Insufficiency and Extreme Prematurity that is active but no longer recruiting, run by Sharp HealthCare. The registered enrollment target is 140 participants, below the 737-participant average among 10 other Respiratory Insufficiency trials with a reported enrollment target (81% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04413097, a NA study of Respiratory Insufficiency and Extreme Prematurity, is active but no longer recruiting, sponsored by Sharp HealthCare.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).
Primary Outcome
To assess the feasibility and compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 MOL given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).
Conditions Studied
Interventions
- PROCEDURE Delayed Cord Clamping with Low Oxygen concentration
- PROCEDURE Delayed Cord Clamping with High Oxygen concentration
Study Locations (3)
California
- University of California Davis - Davis
- University of California San Diego Jacobs Medical Center - San Diego
- Sharp Mary Birch Hospital for Women and Newborns - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What the registry record for NCT04413097 still lists
NCT04413097 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 737-participant average among 10 other Respiratory Insufficiency trials with a reported enrollment target (81% lower).
The record links to 5 conditions, with Respiratory Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which Delayed Cord Clamping with Low Oxygen concentration is the first listed.
NCT04413097 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04413097 about?
NCT04413097 is a clinical study titled "Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants". This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2...
What is the current status of trial NCT04413097?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2021-11-17. Estimated completion is 2026-05-31.
What conditions does trial NCT04413097 study?
This clinical trial studies the following conditions: Respiratory Insufficiency, Extreme Prematurity, Hyperoxia, IVH- Intraventricular Hemorrhage, Hypoxia Neonatal.
What interventions are being tested in trial NCT04413097?
The interventions under investigation include: Delayed Cord Clamping with Low Oxygen concentration (PROCEDURE), Delayed Cord Clamping with High Oxygen concentration (PROCEDURE).
Who is sponsoring clinical trial NCT04413097?
This trial is sponsored by Sharp HealthCare, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04413097 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04413097's enrollment target sits among peer trials
140 4th of 10 higher than 7 of 10 other Respiratory Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Insufficiency 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.
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