Who is sponsoring NCT04413097?

NCT04413097 is sponsored by Sharp HealthCare.

What drugs are being tested in NCT04413097?

Interventions in NCT04413097: Delayed Cord Clamping with Low Oxygen concentration, Delayed Cord Clamping with High Oxygen concentration.

What condition does NCT04413097 study?

NCT04413097 studies IVH- Intraventricular Hemorrhage, Extreme Prematurity, Hypoxia Neonatal, Hyperoxia, Respiratory Insufficiency.

Is NCT04413097 still recruiting?

NCT04413097 is currently active, enrolled. Last updated 12 June 2025.

Last reviewed 2025-06-12 · How we verify

NCT04413097: DOXIE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants

Active, enrolled NA Last updated 12 June 2025

What this trial tests

NA trial testing Delayed Cord Clamping with Low Oxygen concentration in IVH- Intraventricular Hemorrhage in 140 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 November 2021

Primary endpoint
19 May 2025

31 May 2026

Quick facts

Lead sponsor	Sharp HealthCare
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	140
Start date	17 November 2021
Primary completion	19 May 2025
Estimated completion	31 May 2026
Sites	3 locations across United States

Drugs / interventions tested

Delayed Cord Clamping with Low Oxygen concentration
Delayed Cord Clamping with High Oxygen concentration

Conditions studied

IVH- Intraventricular Hemorrhage — all drugs for IVH- Intraventricular Hemorrhage →
Extreme Prematurity — all drugs for Extreme Prematurity →
Hypoxia Neonatal — all drugs for Hypoxia Neonatal →
Hyperoxia — all drugs for Hyperoxia →

Sponsor

Sharp HealthCare

Who can join

Adults 22 Weeks to 28 Weeks, any sex, with IVH- Intraventricular Hemorrhage or Extreme Prematurity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Deferred Cord Clamping With High Oxygen in Extremely Preterm Infants: A Randomized Clinical Trial.
Katheria AC, Ines F, Lee HC, Sollinger C, et al · · 2025 · cited 8× · PMID 40690234 · DOI 10.1001/jamapediatrics.2025.2128
Necrotizing Enterocolitis: What's New and What's Next?
Sha C, Sander WR, Bass K, Hsieh H, et al · · 2025 · cited 1× · PMID 41096926 · DOI 10.3390/ijms26199660
Optimizing transition: Providing oxygen during intact cord resuscitation.
Edwards H, Dorner RA, Katheria AC. · · 2023 · cited 1× · PMID 37380527 · DOI 10.1016/j.semperi.2023.151787

Verify or expand the search:

Other Sharp HealthCare trials

Trials by the same sponsor.

NCT07301385 — Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety a · NA · recruiting
NCT07176117 — Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants · NA · not yet recruiting
NCT07028359 — Sharp Health Companion App for Cataract Surgery Preparation and Recovery · NA · completed
NCT04848727 — Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants · completed
NCT04587934 — Time to Accurate Heart Rate on Neonatal Outcomes · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04413097 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sharp HealthCare
Last refreshed: 12 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04413097.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing