VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/27/2019 |
| Start Date: | June 2016 |
| End Date: | June 2023 |
| Contact: | Steven A Fowler |
| Email: | SAF2QH@virginia.edu |
| Phone: | (434) 243-4730 |
The purpose of this study is to determine whether providing ventilatory assistance prior to
umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in
extremely preterm (EPT) infants, compared to standard care of providing ventilatory
assistance after cord clamping.
umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in
extremely preterm (EPT) infants, compared to standard care of providing ventilatory
assistance after cord clamping.
940 newborns with gestation 23 wks 0 days through 28 wks 6 days Randomized to Standard arm
(delayed cord clamping for 30 seconds, or up to 60 seconds if breathing spontaneously) or
VentFirst arm (receive CPAP or PPV from 30 sec to 120 sec).
Primary outcome is lack of IVH on 7-10 day head ultrasound.
(delayed cord clamping for 30 seconds, or up to 60 seconds if breathing spontaneously) or
VentFirst arm (receive CPAP or PPV from 30 sec to 120 sec).
Primary outcome is lack of IVH on 7-10 day head ultrasound.
Inclusion Criteria:
- 23 0/7 - 28 6/7 weeks gestation at delivery.
Exclusion Criteria:
- Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal
abnormality, severe congenital malformation)
- Suspected severe fetal anemia
- Monochorionic or monoamniotic twins
- Multiple gestation greater than twins
- Decision made for comfort care only
- Medical emergency necessitating emergency delivery (e.g. complete placental abruption)
- Obstetrician or Neonatology concern for inappropriateness of the study intervention
based on maternal or fetal factors.
We found this trial at
10
sites
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-6626
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-305-8500
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1 Shields Ave
Sacramento, California 95616
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Mark Underwood, MD
Phone: 916-734-8121
University of California-Davis As we begin our second century, UC Davis is poised to become...
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