C-UCM and Cerebral Oxygenation and Perfusion

NCT03748914 | Completed

• 2 other identifiers: 30-450 ex 17/18U1111-1223-3280
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Term Infant; Transition

Outcome Measures

Primary Outcomes (1)

• Cerebral blood volume

  Changes in CBV (ml/100g brain)

  within the first 15 minutes after birth.

Secondary Outcomes (6)

• Cerebral tissue oxygenation index

  within the first 15 minutes after birth

• Peripheral oxygen saturation

  within the first 15 minutes after birth

• Heart rate

  within the first 15 minutes after birth

• Stroke volume

  within the first 15 minutes after birth

• Cardiac output

  within the first 15 minutes after birth

Study Arms (2)

Intervention Group

EXPERIMENTAL

Milking the cut umbilical cord once towards the Infant at a speed of 10cm/second.

Other: Intervention Group

Control Group

ACTIVE COMPARATOR

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

Other: Control Group

Interventions

Intervention Group OTHER

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.

Also known as: Cut umbilical cord milking (C-UCM)

Intervention Group

Control Group OTHER

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

Also known as: Standard care

Control Group

Eligibility Criteria

• Age: 1 Minute - 15 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Dep. of Pediatrics, Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Control Groups; Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Berndt Urlesberger, Professor

  Division of Neonatology, Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 21, 2018
• Study Start: November 21, 2018
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)