Status:
ACTIVE_NOT_RECRUITING
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
Lead Sponsor:
Sharp HealthCare
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sharp Mary Birch Hospital for Women & Newborns
Conditions:
IVH- Intraventricular Hemorrhage
Extreme Prematurity
Eligibility:
All Genders
22-28 years
Phase:
NA
Brief 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 ...
Detailed Description
Prenatal consent will be obtained on infant's with estimated gestational age up to 28+6 weeks. Shortly before delivery, infant's will be randomly assigned to receive either Low oxygen concentration (F...
Eligibility Criteria
Inclusion
- up to 28+6 weeks Gestational age
- Single and Multiple pregnancy
- All modes of delivery (vaginally or caesarean section)
Exclusion
- 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
Key Trial Info
Start Date :
November 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04413097
Start Date
November 17 2021
End Date
May 31 2026
Last Update
June 12 2025
Active Locations (3)
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1
University of California Davis
Davis, California, United States, 95817
2
University of California San Diego Jacobs Medical Center
San Diego, California, United States, 92037
3
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123