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

NCT ID: NCT02763436

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-08

Study Completion Date

2019-08-30

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.

Conditions

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Near-Infrared Spectroscopy Umbilical Cord Issue

Keywords

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Neonatal transition Umbilical cord clamping Regional cerebral oxygen saturation Cerebral blood volume Near-infrared spectroscopy Arterial oxygen saturation Term infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

physiological-based cord clamping

Intervention Type PROCEDURE

The cord of the newborn infant is clamped after establishing stable breathing efforts. The suspected time ranges from 2-4 minutes.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

0 Minutes

Maximum Eligible Age

30 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Schwaberger Bernhard, MD PhD

Ass.Dr. (MD) Mirjam Pocivalnik

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernhard Schwaberger, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 25368858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23401615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25540147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25689406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7671435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20439604 (View on PubMed)

Schwaberger B, Ribitsch M, Pichler G, Krainer M, Avian A, Baik-Schneditz N, Ziehenberger E, Mileder LP, Martensen J, Mattersberger C, Wolfsberger CH, Urlesberger B. Does physiological-based cord clamping improve cerebral tissue oxygenation and perfusion in healthy term neonates? - A randomized controlled trial. Front Pediatr. 2023 Jan 9;10:1005947. doi: 10.3389/fped.2022.1005947. eCollection 2022.

Reference Type DERIVED
PMID: 36699304 (View on PubMed)

Other Identifiers

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28-078 ex 15/16

Identifier Type: -

Identifier Source: org_study_id