Physiological Effects of Deferred Cord Clamping (DoppCord)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01864421
First received: May 21, 2013
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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
Deferred Umbilical Cord Clamping

Study Type: Observational
Study Design: 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

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864421

Contacts
Contact: Don Sharkey, BMBS PhD don.sharkey@nottingham.ac.uk

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

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01864421     History of Changes
Other Study ID Numbers: 13023, 13/EM/0129
Study First Received: May 21, 2013
Last Updated: August 13, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Nottingham:
Infant, Newborn
Delivery, Obstetric
Umbilical Cord

ClinicalTrials.gov processed this record on October 19, 2014