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Physiological Effects of Deferred Cord Clamping (DoppCord)

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. Identifier: NCT01864421
Recruitment Status : Terminated (New data in public domain suggested continuing study not ethical)
First Posted : May 29, 2013
Last Update Posted : May 17, 2018
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
This is an observational study to see if at birth, flow of blood from a placenta to the baby can be estimated non-invasively using Doppler ultrasound and/or cutaneous perfusion measured using a novel PPG sensor.

Condition or disease
Deferred Umbilical Cord Clamping

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Delivery Room and Postnatal Assessment of the Physiological Effects of Deferred Cord Clamping on the Newborn: A Feasibility Study
Study Start Date : May 2013
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Deferred Clamping
Infants undergoing a deferring of umbilical cord clamping for 30 seconds or more
Immeadiate Cord Clamping
Infants undergoing immediate umbilical cord clamping in the first 20 seconds of life.

Primary Outcome Measures :
  1. Quantification of blood flow in the umbilical cord or skin [ Time Frame: For Doppler the umbilical cord will be scanned until it is clamped (up to 3 minutes). Blood flow to the skin will be measured for up to 20 minutes as long as this is not interfering with normal clinical care. ]
    The use of either Doppler ultrasound or a photoplethysmographic (PPG) sensor at delivery to measure either blood flow in the umbilical cord or the skin.

Secondary Outcome Measures :
  1. To assess the cardiovascular status of infants undergoing deferred cord clamping in comparison to immediate clamping. [ Time Frame: In the first 3 days after birth. ]
    A number of markers of cardiovascular status will be measured including central and peripheral capillary refill time using a PPG sensor and by the investigators observation, non-invasive blood pressure, heart rate, haemoglobin and haematocrit.

Biospecimen Retention:   Samples Without DNA
Umbilical Cord and Blood

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will recruit babies born at or after 32 weeks with no antenatal or perinatal risk factors that may necessitate the need for resuscitation beyond normal thermal management in the delivery room.

Inclusion Criteria:

  • Greater than ≥ 32 weeks gestation
  • With written informed parental consent

Exclusion Criteria:

  • Antenatally diagnosed problems requiring immediate intervention or problems at delivery are anticipated.
  • No realistic prospect of survival
  • No parental consent
  • Maternal death
  • Non-singleton pregnancies

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 identifier (NCT number): NCT01864421

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United Kingdom
University Hospitals Nottingham NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
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Principal Investigator: Don Sharkey, BMBS PhD Univeristy of Nottingham

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Responsible Party: University of Nottingham Identifier: NCT01864421     History of Changes
Other Study ID Numbers: 13023
13/EM/0129 ( Other Identifier: Research Ethics Committee - Nottingham 2 )
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: February 2016
Keywords provided by University of Nottingham:
Infant, Newborn
Delivery, Obstetric
Umbilical Cord