Aeration, Breathing, Clamping Study 3

Summary

Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages. However, preterm infants needing immediate interventions for stabilisation or resuscitation were generally clamped immediately and excluded from trials, while these infants might benefit the most of DCC.

Studies in preterm lambs demonstrated that delaying cord clamping beyond ventilation onset resulted in more stable hemodynamic transition. This approach was called 'physiological-based cord clamping' (PBCC). The hypothesis of this study is that PBCC in preterm infants at birth will lead to an increase in intact survival when compared to standard care.

This study is a multicentre randomised controlled, parallel design, superiority trial, including preterm infants less than 30 weeks of gestation. The intervention is PBCC: stabilisation of the infant with the umbilical cord intact and only clamp the cord when the infant is stable. Stable is defined as the establishment of heart rate greater than 100 bpm and oxygen saturation above 85% while using supplemental oxygen lower than 40%. In the control group cord clamping will be performed time-based: infants are clamped first (at 30-60 seconds if the clinical condition allows) and then moved to the resuscitation table for further stabilisation.

The primary outcome will be intact survival at NICU discharge, defined as survival without cerebral injury (intraventricular haemorrhage ≥ grade 2 and/or periventricular leukomalacia ≥ grade 2 and/or periventricular venous infarction) and/or necrotizing enterocolitis (Bell stage ≥ 2).

Conditions

• Preterm Infant
• Birth, Preterm

Interventions

PROCEDURE

Physiological-based cord clamping

See Arm description.

PROCEDURE

Time-based cord clamping

See Arm description.

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Medical Research Foundation, The Netherlands

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• Arjan B Te Pas, Prof · Leiden University Medical Centre

• Ronny Knol, MD · Erasmus Medical Centre Rotterdam

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

29 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-25

Primary Completion

2023-05-15

Completion

2025-05-01

Countries

• Netherlands

Study Locations