Active — Not RecruitingNot Applicable

Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants

United States140 participantsStarted 2021-11-17

Plain-language 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).

Who can participate

Age range22 Weeks – 28 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * up to 28+6 weeks Gestational age * Single and Multiple pregnancy * All modes of delivery (vaginally or caesarean section) Exclusion Criteria: * Parents decline consent * Congenital anomalies of the newborn * Bleeding Accreta * Monochorionic multiples with evidence of TTTS * Fetal or maternal risk (i.e. compromise) * Preterm Premature Rupture of Membranes prior to 20 weeks gestation * Parents request no resuscitation

What they're measuring

Feasibility of administration of oxygen during delayed cord clamping and it's impact on the incidence of preterm infants (up to 28 +6 weeks) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life

Timeframe: by 5 minutes of life

Trial details

NCT IDNCT04413097

SponsorSharp HealthCare

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-19

View on ClinicalTrials.gov More IVH- Intraventricular Hemorrhage trials