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C-UCM and Cerebral Oxygenation and Perfusion

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ClinicalTrials.gov Identifier: NCT03748914
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
In this randomized controlled Pilot study the effects of cut-umbilical cord milking on cerebral oxygenation and perfusion measured via near-infrared spectroscopy (NIRS) and the effects on stroke volume (SV) and cardiac output (CO) also measured non-invasively in term and preterm infants are evaluated for the first 15 minutes after birth and compared to a control group.

Condition or disease Intervention/treatment Phase
Preterm Infant Term Infant Transition Other: Intervention Group Other: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Influence of Cut-umbilical Cord Milking (C-UCM) on the Cerebral Oxygenation and Perfusion of Preterm and Term Infants
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Intervention Group
Milking the cut umbilical cord once towards the Infant at a speed of 10cm/second.
Other: Intervention Group
After delivery of the neonate via caesarean section the umbilical cord will be clamped within 30 seconds and cut long at least 30 cm by the obstetrician. The neonate is then placed under an overhead heater by the midwife. There, the umbilical cord must be untwisted and held in a vertical position. It is milked once by the neonatologist towards the baby at a speed of approximately 10 cm/s and then clamped 3 cm from the umbilicus by one member of the clinical team.
Other Name: Cut umbilical cord milking (C-UCM)

Active Comparator: Control Group
The umbilical cord is cut according to the standard procedure and no C-UCM is performed.
Other: Control Group
The umbilical cord is cut according to the standard procedure and no C-UCM is performed.
Other Name: Standard care




Primary Outcome Measures :
  1. Cerebral blood volume [ Time Frame: within the first 15 minutes after birth. ]
    Changes in CBV (ml/100g brain)


Secondary Outcome Measures :
  1. Cerebral tissue oxygenation index [ Time Frame: within the first 15 minutes after birth ]
    Changes in cTOI (%)

  2. Peripheral oxygen saturation [ Time Frame: within the first 15 minutes after birth ]
    Changes in SpO2 (%)

  3. Heart rate [ Time Frame: within the first 15 minutes after birth ]
    Changes in HR (beats per minute)

  4. Stroke volume [ Time Frame: within the first 15 minutes after birth ]
    Changes in SV (ml)

  5. Cardiac output [ Time Frame: within the first 15 minutes after birth ]
    Changes in CO (l/min)

  6. Mean arterial blood pressure [ Time Frame: within the first 15 minutes after birth ]
    Changes in MABP (mmHg)



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Ages Eligible for Study:   up to 15 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Neonates with a gestational age ≥28 weeks
  • Delivered by caesarean section
  • Decision to conduct full life support
  • Written informed consent prior to birth

Exclusion Criteria:

  • Neonates with a gestational age <28 weeks
  • No decision to conduct full life support
  • No written informed consent
  • Severe congenital malformations

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): NCT03748914


Contacts
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Contact: Berndt Urlesberger, Professor +4331638581133 berndt.urlesberger@medunigraz.at
Contact: Bernhard Schwaberger, MD, PhD +4331638530018 bernhard.schwaberger@medunigraz.at

Locations
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Austria
Dep. of Pediatrics, Medical University of Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Gerhard Pichler, MD    +43 316 385 50520    gerhard.pichler@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Berndt Urlesberger, Professor Division of Neonatology, Medical University of Graz
  Study Documents (Full-Text)

Documents provided by Medical University of Graz:
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03748914    
Other Study ID Numbers: 30-450 ex 17/18
U1111-1223-3280 ( Other Identifier: WHO Universal Trial Number (UTN) )
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications