Reducing Oxygen Toxicity in Very Preterm Infants through Physiologically Based Cord Clamping (PBCC) Compared to Delayed Cord Clamping (DCC): A Prospective, Randomized Controlled Trial on Cumulative Oxygen Exposure in the First 10 Minutes of Life

Reducing Oxygen Toxicity in Very Preterm Infants through Physiologically Based Cord Clamping (PBCC) Compared to Delayed Cord Clamping (DCC): A Prospective, Randomized Controlled Trial on Cumulative Oxygen Exposure in the First 10 Minutes of Life - RedOxTox

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036869

Enrollment

150

Registered

2025-05-15

Start date

2026-12-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.3

Interventions

Group 1: Physiologically Based Cord Clamping (PBCC) – Neonatal stabilization at the intact umbilical cord using the Concord Birth Trolley® Group 2: Delayed Cord Clamping (DCC) – Clamping after 30–60 s

Eligibility

Sex/Gender

All

Age

0 Days to 0 Days

Inclusion criteria

Inclusion criteria: Preterm infants with gestational age between 28+0 and 32+0 weeks Written informed consent from legal guardians obtained before delivery

Exclusion criteria

Exclusion criteria: Preterm or newborn infants with major congenital malformations affecting: respiratory regulation (e.g., severe CNS malformations), lung function (e.g., pulmonary hypoplasia, diaphragmatic hernia), or cardiovascular function (e.g., cyanotic congenital heart defects) Lack of parental consent prior to delivery

Design outcomes

Primary

Measure	Time frame
Cumulative FiO2 requirement between minutes 2 and 10 of life, needed to achieve predefined SpO2 target values.	—

Secondary

Measure	Time frame
Time to achieve HR >100 bpm, SpO2 >88%, and FiO2 <0.4 Temperature during initial stabilization and upon admission Hematocrit levels and need for transfusion Requirement and duration of phototherapy Duration and necessity of respiratory support (invasive and non-invasive) Requirement for circulatory support (volume, hydrocortisone, catecholamines) Administration of surfactant Incidence of hypoglycemia, IVH, BPD, ROP, postnatal steroid use, and sepsis/infection Measurement of biomarkers for lung injury and oxygen toxicity in blood and urine	—

Measure

Time frame

Time to achieve HR >100 bpm, SpO2 >88%, and FiO2 <0.4 Temperature during initial stabilization and upon admission Hematocrit levels and need for transfusion Requirement and duration of phototherapy Duration and necessity of respiratory support (invasive and non-invasive) Requirement for circulatory support (volume, hydrocortisone, catecholamines) Administration of surfactant Incidence of hypoglycemia, IVH, BPD, ROP, postnatal steroid use, and sepsis/infection Measurement of biomarkers for lung injury and oxygen toxicity in blood and urine

—

Countries

Germany

Contacts

Public ContactHarald Ehrhardt

Universitätsklinikum Ulm – Klinik für Kinder- und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin

harald.ehrhardt@uniklinik-ulm.de+49731 500 57168

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026