VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Not Applicable

Completed

• Conditions: Infant, Premature, Diseases
• Interventions: Procedure: CPAP or PPV during DCC

• Registration Number: NCT02391389
• Lead Sponsor: University of Virginia

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 Description

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-18
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 24 0/7 to 32 6/7 weeks gestation at birth

Exclusion Criteria

• major congenital anomalies
• monochorionic twins
• twin-twin transfusion syndrome
• hydrops fetalis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP or PPV during DCC	CPAP or PPV during DCC	Infant will receive CPAP or PPV from 30 to 90 seconds after birth while attached to the placenta, and then the umbilical cord will be cut at 90 seconds

Primary Outcome Measures

Name	Time	Method
Number of deliveries in which providing ventilatory assistance during delayed cord clamping is achieved	90 seconds after birth	Assess the feasibility of the neonatology team performing initial resuscitation and providing ventilation during 90 seconds of delayed cord clamping

Secondary Outcome Measures

Name	Time	Method
Number of unanticipated complications of neonatal resuscitation during delayed cord clamping (neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables)	7 days from birth	Assess neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables

Trial Locations

Locations (1)

University of Virginia School of Medicine; 🇺🇸 Charlottesville, Virginia, United States