Clinical Trial: VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Brief Summary: Delayed clamping of the umbilical cord (DCC) has been shown to have some benefits for preterm infants. Initiation of breathing before cord clamping is also thought to be beneficial. Since some preterm infants do not breathe well on their own immediately after birth, assisting ventilation during delayed cord clamping might have additional benefit beyond DCC alone. "VentFirst Pilot" will assess feasibility and safety of assisting ventilation of preterm infants during 90 seconds of DCC which is essential before proceeding to a randomized clinical trial.

Detailed Summary: Mothers expected to deliver an infant at 24-32 completed weeks' gestation will be approached for consent. When the infant is delivered, members of the neonatology team will be at the mother's side and will provide initial steps of resuscitation (position, suction, stimulate) per guidelines of the Neonatology Resuscitation Program (NRP). At 30 seconds after birth, the infant will receive continuous positive airway pressure (CPAP) if breathing well, or positive pressure ventilation (PPV) if not breathing well. At 90 seconds, the umbilical cord will be cut and the remainder of the resuscitation and stabilization will be carried out in the usual location.
Sponsor: University of Virginia

Current Primary Outcome: Number of deliveries in which providing ventilatory assistance during delayed cord clamping is achieved [ Time Frame: 90 seconds after birth ]

Assess the feasibility of the neonatology team performing initial resuscitation and providing ventilation during 90 seconds of delayed cord clamping


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of unanticipated complications of neonatal resuscitation during delayed cord clamping (neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables) [ Time Frame: 7 days from birth ]

Assess neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: December 8, 2014
Date Started: September 2014
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017