Skip to main content
OpenTrials
Completed

NCT Number: NCT03808051

Aeration, Breathing, Clamping Study 3

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Infant Birth, Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 29 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University Medical Centre, location AMC, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiological-based cord clamping

Procedure

See Arm description.

Time-based cord clamping

Procedure

See Arm description.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Erasmus Medical Center
  • Medical Research Foundation, The Netherlands

Registry information

Official study title

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

Acronym: ABC3

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Jan 17, 2019
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.