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

Near-Infrared Spectroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763436
• Other study ID #: 28-078 ex 15/16
• Status: Completed
• Phase: N/A
• Start date: September 8, 2016
• Est. completion date: August 30, 2019

Study information

• Verified date: December 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Minutes

Eligibility

Inclusion Criteria:

• Vaginally born and term infants

• undisturbed transition period

Exclusion Criteria:

• congenital malformations

• respiratory support during transition period

Related Conditions & MeSH terms

• Near-Infrared Spectroscopy
• Umbilical Cord Issue

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (6)

Bhatt S, Alison BJ, Wallace EM, Crossley KJ, Gill AW, Kluckow M, te Pas AB, Morley CJ, Polglase GR, Hooper SB. Delaying cord clamping until ventilation onset improves cardiovascular function at birth in preterm lambs. J Physiol. 2013 Apr 15;591(8):2113-26. doi: 10.1113/jphysiol.2012.250084. Epub 2013 Feb 11. — View Citation

Bhatt S, Polglase GR, Wallace EM, Te Pas AB, Hooper SB. Ventilation before Umbilical Cord Clamping Improves the Physiological Transition at Birth. Front Pediatr. 2014 Oct 20;2:113. doi: 10.3389/fped.2014.00113. eCollection 2014. Review. — View Citation

Dawson JA, Kamlin CO, Vento M, Wong C, Cole TJ, Donath SM, Davis PG, Morley CJ. Defining the reference range for oxygen saturation for infants after birth. Pediatrics. 2010 Jun;125(6):e1340-7. doi: 10.1542/peds.2009-1510. Epub 2010 May 3. — View Citation

Hooper SB, Harding R. Fetal lung liquid: a major determinant of the growth and functional development of the fetal lung. Clin Exp Pharmacol Physiol. 1995 Apr;22(4):235-47. Review. — View Citation

Hooper SB, Polglase GR, te Pas AB. A physiological approach to the timing of umbilical cord clamping at birth. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F355-60. doi: 10.1136/archdischild-2013-305703. Epub 2014 Dec 24. Review. — View Citation

Polglase GR, Dawson JA, Kluckow M, Gill AW, Davis PG, Te Pas AB, Crossley KJ, McDougall A, Wallace EM, Hooper SB. Ventilation onset prior to umbilical cord clamping (physiological-based cord clamping) improves systemic and cerebral oxygenation in preterm lambs. PLoS One. 2015 Feb 17;10(2):e0117504. doi: 10.1371/journal.pone.0117504. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Evaluation of cardiac shunt parameters	Collection of the following parameters using echocardiography: shuntdirection and diameter of the Ductus arteriosus and Foramen ovale.	20 minutes
Secondary	Evaluation of preload parameters	Collection of the following parameters using echocardiography: superior vena cava (SVC) Flow and inferior vena cava (IVC) size.	20 minutes
Secondary	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
Secondary	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