Clinical trial NCT02763436: "Improves Physiological Based Cord Clamping (PBCC) the Systemic and Cerebral Oxygenation in Term Infants?"
Official title: "Improves Physiological Based Cord Clamping (PBCC) the Systemic and Cerebral Oxygenation in Term Infants?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Near-Infrared Spectroscopy
Umbilical Cord Issue
Keywords: Neonatal transition
Umbilical cord clamping
Regional cerebral oxygen saturation
Cerebral blood volume
Near-infrared spectroscopy
Arterial oxygen saturation
Term infants
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 78
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Vaginally born and term infants
* undisturbed transition period

Exclusion Criteria:

* congenital malformations
* respiratory support during transition period

Primary outcomes:
measure: Change in cerebral regional oxygen saturation (crSO2)
timeFrame: 15 minutes
Secondary outcomes:
measure: Change in peripheral arterial oxygen saturation (SpO2)
timeFrame: 15 minutes
measure: Change in Cerebral blood volume (CBV)
timeFrame: 15 minutes
measure: Evaluation of cardiac shunt parameters
timeFrame: 20 minutes
measure: Evaluation of preload parameters
timeFrame: 20 minutes
measure: right atrial (RA) and right ventricular (RV) dimension parameters
timeFrame: 20 minutes
measure: right ventricular (RV) systolic function
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Bernhard Schwaberger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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. doi: 10.1111/j.1440-1681.1995.tb01988.x.
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.