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VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

Primary Purpose

Infant, Premature, Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP or PPV during DCC
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring preterm infant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Virginia School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP or PPV during DCC

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2014
Last Updated
January 10, 2017
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02391389
Brief Title
VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping
Official Title
VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases
Keywords
preterm infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP or PPV during DCC
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
CPAP or PPV during DCC
Intervention Description
CPAP or PPV is provided during delayed cord clamping
Primary Outcome Measure Information:
Title
Number of deliveries in which providing ventilatory assistance during delayed cord clamping is achieved
Description
Assess the feasibility of the neonatology team performing initial resuscitation and providing ventilation during 90 seconds of delayed cord clamping
Time Frame
90 seconds after birth
Secondary Outcome Measure Information:
Title
Number of unanticipated complications of neonatal resuscitation during delayed cord clamping (neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables)
Description
Assess neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables
Time Frame
7 days from birth

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen D Fairchild, MD
Organizational Affiliation
University of Virginia SOM
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27305177
Citation
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.
Results Reference
result

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VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping

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