UnknownNot Applicable

VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants

United States570 participantsStarted 2016-06

Plain-language summary

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.

Who can participate

SexALL

See this in plain English?

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

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.

What they're measuring

Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age

Timeframe: 7-10 days after birth

Trial details

NCT IDNCT02742454

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03

View on ClinicalTrials.gov More Intraventricular Hemorrhage trials