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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Near-Infrared Spectroscopy, Umbilical Cord Issue

Intervention / Treatment
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* Procedure: physiological-based cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaginally born and term infants undisturbed transition period Exclusion Criteria: congenital malformations respiratory support during transition period

Ages Eligible for Study
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Minimum Age: 0 Minutes
Maximum Age: 30 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group immediate cord clamping (ICC)<br>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)<br>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<br>* The cord of the newborn infant is clamped after establishing stable breathing efforts. The suspected time ranges from 2-4 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral regional oxygen saturation (crSO2) | 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) | 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) | 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 | Collection of the following parameters using echocardiography: shuntdirection and diameter of the Ductus arteriosus and Foramen ovale. | 20 minutes | 
| Evaluation of preload parameters | 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 | 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 | Calculation of the following parameters using echocardiography: TAPSE (tricuspid annular plane systolic excursion) as a measure of systolic right ventricular function. | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal transition, Umbilical cord clamping, Regional cerebral oxygen saturation, Cerebral blood volume, Near-infrared spectroscopy, Arterial oxygen saturation, Term infants