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

Medical University of Graz

Status: Completed

Conditions: Umbilical Cord Issue; Near-Infrared Spectroscopy

Treatments: Procedure: physiological-based cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT02763436

28-078 ex 15/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: Under 30 minutes old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vaginally born and term infants
• undisturbed transition period

Exclusion criteria

• congenital malformations
• respiratory support during transition period

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Group "immediate cord clamping" (ICC)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Procedure: physiological-based cord clamping