NCT02763436

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 0 Minutes – 30 Minutes
• Healthy volunteers: Not accepted

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.

Conditions

• Near-Infrared Spectroscopy
• Umbilical Cord Issue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-08
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2016-05-05
• Last updated: 2020-12-22

Locations

1 site across 1 country: Austria