VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Infant, Premature, Diseases Clinical Trial

Official title:

VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391389
• Other study ID #: 17444
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: January 10, 2017
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2017
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

Procedure:
• CPAP or PPV during DCC
CPAP or PPV is provided during delayed cord clamping

Locations

Country	Name	City	State
United States	University of Virginia School of Medicine	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Winter J, Kattwinkel J, Chisholm C, Blackman A, Wilson S, Fairchild K. Ventilation of Preterm Infants during Delayed Cord Clamping (VentFirst): A Pilot Study of Feasibility and Safety. Am J Perinatol. 2016 Jun 15. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of deliveries in which providing ventilatory assistance during delayed cord clamping is achieved	Assess the feasibility of the neonatology team performing initial resuscitation and providing ventilation during 90 seconds of delayed cord clamping	90 seconds after birth	No
Secondary	Number of unanticipated complications of neonatal resuscitation during delayed cord clamping (neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables)	Assess neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables	7 days from birth	Yes