Aeration, Breathing, Clamping Study 3 (ABC3)

May 9, 2023 updated by: PasABte, Leiden University Medical Center

Physiological-based Cord Clamping in Very Preterm Infants: a Multicentre Randomised Controlled Trial.

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

689

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Amsterdam, Netherlands
        • Amsterdam University Medical Centre, location AMC
      • Amsterdam, Netherlands
        • Amsterdam University Medical Centre, location VU
      • Groningen, Netherlands
        • University Medical Centre Groningen
      • Leiden, Netherlands
        • Leiden University Medical Centre
      • Maastricht, Netherlands
        • Maastricht University Medical Centre
      • Nijmegen, Netherlands
        • Radboud university medical centre
      • Rotterdam, Netherlands
        • Erasmus Medical Centre - Sophia Children's Hospital
      • Utrecht, Netherlands
        • University Medical Centre Utrecht
      • Veldhoven, Netherlands
        • Maxima Medical Centre
      • Zwolle, Netherlands
        • Isala Clinics Zwolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants born at a gestational age below 30 weeks in a participating centre.
  • Parental consent (see 9.2).

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • Significant congenital malformations influencing cardiopulmonary transition.
  • Signs of acute placental abruption.
  • Anterior placenta praevia or invasive placentation (accreta/percreta).
  • Birth by emergency caesarean section (ordered to be executed within 15 minutes).
  • Maternal general anaesthesia during caesarean section.
  • Twin gestation with signs of Twin Transfusion Syndrome or Twin Anaemia Polycythemia Syndrome not treated with fetoscopic laser treatment.
  • Multiple pregnancy > 2 (triplets or higher order).
  • Decision documented to give palliative neonatal care.

In case of twin delivery by caesarean section it is not possible to perform PBCC in both infants. Both infants will be included: the first infant will receive standard treatment and the second infant will be randomised to either PBCC or standard treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiological-based cord clamping
Stabilisation of the infant is performed while the cord is intact and the cord will be clamped after the infant is cardiopulmonary 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%. The maximum cord clamping time is 10 minutes and prior to cord clamping a trial of weaning from PPV to CPAP is performed. With the exception that the infant is stabilised close to the mother and the cord is clamped later, the infant will receive standard resuscitation interventions.
See Arm description.
Active Comparator: Time-based cord clamping
Infants are clamped first and then moved to the standard resuscitation table for further treatment and intervention needed for cardiopulmonary stabilisation. Clamping is time based and performed immediately or delayed at 30-60 seconds, depending on the clinical condition of the infant. Uterotonic drugs are administered immediately after cord clamping.
See Arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intact survival at NICU discharge
Time Frame: From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
Intact survival is defined as survival without major cerebral injury (IVH ≥ grade 2 and/or PVL ≥ grade 2 and/or periventricular venous infarction) and/or NEC ≥ Bell stage 2.
From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of treatment failure
Time Frame: From birth until one hour of age.
Treatment failure defined as the number of participants in which abortion of prescribed procedure (intervention or control) occurred and the reasons for abortion.
From birth until one hour of age.
Short-term neonatal outcomes
Time Frame: From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
Incidence of prematurity related morbidities during hospital stay.
From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
Short-term maternal outcomes
Time Frame: From date of randomization until five days after intervention.
Incidence of postpartum haemorrhage (> 1000 ml) and surgical site infection after caesarean section.
From date of randomization until five days after intervention.
Neurodevelopmental outcome (Cognitive) at 2 years corrected age
Time Frame: Assesment at two years corrected age.
Neurodevelopmental outcome assessed at 2 years corrected age by the standardized Bayley Scales of Infant Development III (BSID-III-NL), resulting in the Mental Developmental Index. A score of less than 85 (1 SD below the mean of 100) is considered as delayed development.
Assesment at two years corrected age.
Neurodevelopmental outcome (Motor) at 2 years corrected age
Time Frame: Assesment at two years corrected age.
Neurodevelopmental outcome assessed at 2 years corrected age by the standardized Bayley Scales of Infant Development III (BSID-III-NL), resulting in the Performance Developmental Index. A score of less than 85 (1 SD below the mean of 100) is considered as delayed development.
Assesment at two years corrected age.
Functional outcome at 2 years corrected age
Time Frame: Assesment at two years corrected age.
The proportion of participants with cerebral palsy, the proportion of participants with hearing loss requiring hearing aids and the proportion of participants with blindness.
Assesment at two years corrected age.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental perception and appreciation of stabilisation at birth
Time Frame: Sent within 1 week after birth.
Questionnaire sent to parents concerning the perception and appreciation of the approach during birth and the perinatal stabilisation of the infant.
Sent within 1 week after birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Arjan B Te Pas, Prof, Leiden University Medical Centre
  • Principal Investigator: Ronny Knol, MD, Erasmus Medical Centre Rotterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2019

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

May 15, 2025

Study Registration Dates

First Submitted

January 1, 2019

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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