NCT02391389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

December 8, 2014

Last Update Submit

January 10, 2017

Conditions

Infant, Premature, Diseases

Keywords

preterm infant

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of unanticipated complications of neonatal resuscitation during delayed cord clamping (neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables)

    7 days from birth

Study Arms (1)

CPAP or PPV during DCC

EXPERIMENTAL

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

Procedure: CPAP or PPV during DCC

Interventions

CPAP or PPV during DCCPROCEDURE

CPAP or PPV is provided during delayed cord clamping

CPAP or PPV during DCC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 24 0/7 to 32 6/7 weeks gestation at birth

You may not qualify if:

  • major congenital anomalies
  • monochorionic twins
  • twin-twin transfusion syndrome
  • hydrops fetalis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Location

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

    PMID: 27305177RESULT

MeSH Terms

Conditions

Infant, Premature, DiseasesPremature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Karen D Fairchild, MD

    University of Virginia SOM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

December 8, 2014

First Posted

March 18, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

US(1)