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Completed

NCT Number: NCT02391389

VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

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.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP or PPV during DCC

Procedure

CPAP or PPV is provided during delayed cord clamping

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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