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Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
NCT04413097 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04413097
The ClinicalTrials.gov registry entry for NCT04413097 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sharp HealthCare, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04413097 reports 3 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04413097?
This trial is sponsored by Sharp HealthCare, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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