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Changes in Cardiac Output During Delayed Umbilical Cord Clamping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02195037
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

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

Condition or disease
Cardiac Output, Low

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Cardiac Output During Delayed Umbilical Cord Clamping
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Cardiac Output [ Time Frame: 5 minutes of Life ]

Secondary Outcome Measures :
  1. Stroke Volume [ Time Frame: 5 Minutes of Life ]
  2. Bilirubin level [ Time Frame: until discharge ]
  3. Hemoglobin level [ Time Frame: until discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195037


Locations
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United States, California
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123
Sponsors and Collaborators
Sharp HealthCare
Investigators
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Principal Investigator: Anup Katheria, MD Sharp HealthCare
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anup Katheria, M.D., Director of Neonatal Research, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT02195037    
Other Study ID Numbers: CO-DCC
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: August 2014
Keywords provided by Anup Katheria, M.D., Sharp HealthCare:
Delayed Cord Clamping
Additional relevant MeSH terms:
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Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases