Summary

Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
completion around

Description

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.

Details

Newborns with gestational age 23 wks 0 days through 28 wks 6 days are randomized to control (delayed cord clamping for at least 30 seconds, or up to 60 seconds if breathing spontaneously, with ventilatory assistance provided after) or the VentFirst intervention (ventilatory assistance with continuous positive airway pressure or positive pressure ventilation given starting 30 seconds after birth and cord clamping at 120 seconds).

The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7.

The study was designed to test the impact of the intervention in each of two cohorts:

  1. Infants not breathing well 30 seconds after birth
  2. Infants breathing well 30 seconds after birth

Randomization and analysis is stratified by gestational age category:

  1. 23 0/6 to 25 6/7 weeks' gestation
  2. 26 0/7 to 28 6/7 weeks' gestation

Keywords

Intraventricular Hemorrhage, Umbilical Cord Clamping, Extremely Preterm Infants, Hemorrhage, VentFirst 120 Seconds Cord Clamping

Eligibility

You can join if…

- 23 0/7 - 28 6/7 weeks' gestation at delivery

You CAN'T join if...

  • 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.

Locations

  • University of California, Davis
    Sacramento California 95817 United States
  • Oregon Health & Science University
    Portland Oregon 37239-0000 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Virginia
ID
NCT02742454
Study Type
Interventional
Participants
About 570 people participating
Last Updated