VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

NCT ID: NCT02391389

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-06-30

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.

Conditions

Infant, Premature, Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CPAP or PPV during DCC

Intervention Type: PROCEDURE

CPAP or PPV is provided during delayed cord clamping

Interventions

CPAP or PPV during DCC

CPAP or PPV is provided during delayed cord clamping

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Karen Fairchild, MD

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen D Fairchild, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia SOM

Locations

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Countries

United States

References

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. 2017 Jan;34(2):111-116. doi: 10.1055/s-0036-1584521. Epub 2016 Jun 15.

Reference Type: RESULT

PMID: 27305177 (View on PubMed)

Other Identifiers

17444

Identifier Type: -

Identifier Source: org_study_id