VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

University of Virginia

Status: Completed

Conditions: Infant, Premature, Diseases

Treatments: Procedure: CPAP or PPV during DCC

Study type: Interventional

Funder types: Other

Identifiers

NCT02391389

17444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

CPAP or PPV during DCC

Experimental group

Description:

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

Treatment:

Procedure: CPAP or PPV during DCC