NCT02763436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 8, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

3 years

First QC Date

April 2, 2016

Last Update Submit

December 19, 2020

Conditions

Near-Infrared SpectroscopyUmbilical Cord Issue

Keywords

Neonatal transitionUmbilical cord clampingRegional cerebral oxygen saturationCerebral blood volumeNear-infrared spectroscopyArterial oxygen saturationTerm infants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in peripheral arterial oxygen saturation (SpO2)

    15 minutes

  • Change in Cerebral blood volume (CBV)

    15 minutes

  • Evaluation of cardiac shunt parameters

    20 minutes

  • Evaluation of preload parameters

    20 minutes

  • right atrial (RA) and right ventricular (RV) dimension parameters

    20 minutes

  • +1 more secondary outcomes

Study Arms (2)

Group "immediate cord clamping" (ICC)

NO INTERVENTION

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 "physiological based cord clamping" (PBCC)

ACTIVE COMPARATOR

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

Interventions

physiological-based cord clampingPROCEDURE

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

Group "physiological based cord clamping" (PBCC)

Eligibility Criteria

Age0 Minutes - 30 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Vaginally born and term infants
  • undisturbed transition period

You may not qualify if:

  • congenital malformations
  • respiratory support during transition period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (7)

  • 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.

    PMID: 25368858BACKGROUND

  • 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.

    PMID: 23401615BACKGROUND

  • 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.

    PMID: 25540147BACKGROUND

  • 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.

    PMID: 25689406BACKGROUND

  • 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.

    PMID: 7671435BACKGROUND

  • 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.

    PMID: 20439604BACKGROUND

  • 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.

    PMID: 36699304DERIVED

Study Officials

  • Bernhard Schwaberger, MD PhD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Dr. (MD) Mirjam Pocivalnik

Study Record Dates

First Submitted

April 2, 2016

First Posted

May 5, 2016

Study Start

September 8, 2016

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)