"Improves Physiological Based Cord Clamping (PBCC) the Systemic and Cerebral Oxygenation in Term Infants?"

December 19, 2020 updated by: Schwaberger Bernhard, MD PhD, Medical University of Graz
The first major intervention a newborn infant is facing following birth is clamping of the umbilical cord. This means separation of the infant from the placenta, the newborn becomes an independent individual, especially from a cardio-circulatory perspective. There is still a lack of understanding of the issues associated with umbilical cord clamping. The aim of the present study is to investigate whether cord clamping after onset of sufficient spontenous breathing is able to improve systemic and cerebral oxygenation in term infants delivered vaginally.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent literature focused very much on the appropriate timing of the cord clamping (CC), distinguishing immediate cord clamping (ICC) from delayed cord clamping (DCC). Although potential benefits for DCC have been documented, especially for preterm infants, ICC still is the most widely used procedure. Although the reasons for this are unclear, a lack of understanding of the issues associated with umbilical cord clamping is thought to be a major underlying factor.

In animal research with fetal lambs it has been shown, that aeration of the lung played a crucial role in undisturbed cardio-circulatory immediate neonatal transition. Thus a new concept of DCC was introduced, delaying cord clamping until ventilation/aeration of the lung was established, calling this "Physiological-Based Cord Clamping" (PBCC). It was shown, that PBCC improved not only cardiovascular function in preterm lambs, but systemic and cerebral oxygenation too. Systemic oxygenation was measured using pulseoximetry, and cerebral oxygenation was measured using near infrared spectroscopy (NIRS).

Until now, human data for PBCC are lacking. Therefore, the aim of the present study is to investigate whether PBCC is able to improve systemic and cerebral oxygenation in term infants delivered vaginally.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Vaginally born and term infants
  • undisturbed transition period

Exclusion Criteria:

  • congenital malformations
  • respiratory support during transition period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group "immediate cord clamping" (ICC)
The cord will be clamped within the first minute after birth, afterwards the newborn will be placed on the mothers chest/abdomen. This corresponds to the present routine approach in Graz.
Active Comparator: Group "physiological based cord clamping" (PBCC)
The newborn will be placed on mother's chest/abdomen with intact cord. After the newborn has established stable breathing efforts (continuous regular breathing pattern and SpO2 values >25th percentile from Dawson et al "reference range for oxygen saturation" -minute 2>58%, minute 3>67%, minute 4>76%) the cord is clamped. This will need 2 - 4 minutes.
Procedure: physiological-based cord clamping
The cord of the newborn infant is clamped after establishing stable breathing efforts. The suspected time ranges from 2-4 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cerebral regional oxygen saturation (crSO2)
Time Frame: 15 minutes
Difference in the course of postnatal increase of crSO2 (%). crSO2 is measured with nearinfrared spectroscopy (NIRS). Immediately after delivery, the NIRS sensor is placed on the left forehead, measuring crSO2 non-invasively over the observational period.
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peripheral arterial oxygen saturation (SpO2)
Time Frame: 15 minutes
Difference in the course of postnatal increase of SpO2 (%). SpO2 is measured with pulsoximetry, noninvasively. Immediately after delivery, the SpO2 sensor is placed on the right forearm/wrist to monitor peripheral preductal oxygen saturation over the observational period.
15 minutes
Change in Cerebral blood volume (CBV)
Time Frame: 15 minutes
Differences in course of CBV decrease during the observational period. CBV (ml/100gbrain) is calculated out of data measured with NIRS noninvasively : depending on the changes of oxygenated and deoxygenated Hemoglobin.
15 minutes
Evaluation of cardiac shunt parameters
Time Frame: 20 minutes
Collection of the following parameters using echocardiography: shuntdirection and diameter of the Ductus arteriosus and Foramen ovale.
20 minutes
Evaluation of preload parameters
Time Frame: 20 minutes
Collection of the following parameters using echocardiography: superior vena cava (SVC) Flow and inferior vena cava (IVC) size.
20 minutes
right atrial (RA) and right ventricular (RV) dimension parameters
Time Frame: 20 minutes
Collection of the following parameters using echocardiography: end-systolic right atrial size and area, end-diastolic plus end-systolic right ventricle size and area.
20 minutes
right ventricular (RV) systolic function
Time Frame: 20 minutes
Calculation of the following parameters using echocardiography: TAPSE (tricuspid annular plane systolic excursion) as a measure of systolic right ventricular function.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Bernhard Schwaberger, MD PhD, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2016

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

April 2, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 28-078 ex 15/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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