NCT02195037

Brief Summary

Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. The purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

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

July 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

July 17, 2014

Last Update Submit

May 18, 2015

Conditions

Cardiac Output, Low

Keywords

Delayed Cord Clamping

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output

    5 minutes of Life

Secondary Outcomes (3)

  • Stroke Volume

    5 Minutes of Life

  • Bilirubin level

    until discharge

  • Hemoglobin level

    until discharge

Eligibility Criteria

AgeUp to 1 Minute
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy full term infants delivered by vaginal birth with an estimated gestational age of 37+1 to 41+6 weeks corrected gestational age

You may qualify if:

  • Healthy full term infants
  • Delivered by vaginal birth
  • Estimated gestational age of 37+0to 41+6 weeks corrected gestational age

You may not qualify if:

  • Multiples
  • Known fetal anomalies (including cardiac defects).
  • Instrumentation during delivery (forceps or vacuum)
  • Non-reducible nuchal cord during delivery.
  • Any maternal or neonatal indication requiring immediate cord clamping.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (1)

  • Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015.

    PMID: 27057332DERIVED

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anup Katheria, MD

    Sharp HealthCare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neonatal Research

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 21, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

May 20, 2015

Record last verified: 2014-08

Locations

US(1)