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C-UCM and Cerebral Oxygenation and Perfusion

NCT03748914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-03-16

No results posted yet for this study

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.

Conditions

  • Preterm Infant
  • Term Infant
  • Transition

Interventions

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

Control Group

The umbilical cord is cut according to the standard procedure and no C-UCM is performed.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Berndt Urlesberger, Professor · Division of Neonatology, Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
15 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-21
Primary Completion
2019-11-18
Completion
2019-11-18

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03748914 on ClinicalTrials.gov