Near-Infrared Spectroscopy, Umbilical Cord Issue
Conditions
Keywords
Neonatal transition, Umbilical cord clamping, Regional cerebral oxygen saturation, Cerebral blood volume, Near-infrared spectroscopy, Arterial oxygen saturation, Term infants
Brief summary
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
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.
Interventions
PROCEDUREphysiological-based cord clamping
The cord of the newborn infant is clamped after establishing stable breathing efforts. The suspected time ranges from 2-4 minutes.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Minutes to 30 Minutes
Healthy volunteers
No
Inclusion criteria
* Vaginally born and term infants * undisturbed transition period
Exclusion criteria
* congenital malformations * respiratory support during transition period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cerebral regional oxygen saturation (crSO2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cerebral blood volume (CBV) | 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. |
| Evaluation of cardiac shunt parameters | 20 minutes | Collection of the following parameters using echocardiography: shuntdirection and diameter of the Ductus arteriosus and Foramen ovale. |
| Change in peripheral arterial oxygen saturation (SpO2) | 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. |
| right atrial (RA) and right ventricular (RV) dimension parameters | 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. |
| right ventricular (RV) systolic function | 20 minutes | Calculation of the following parameters using echocardiography: TAPSE (tricuspid annular plane systolic excursion) as a measure of systolic right ventricular function. |
| Evaluation of preload parameters | 20 minutes | Collection of the following parameters using echocardiography: superior vena cava (SVC) Flow and inferior vena cava (IVC) size. |
Countries
Austria
Outcome results
None listed