Aeration, Breathing, Clamping Study 3 (ABC3)

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Preterm Infant; Birth, Preterm

Treatments: Procedure: Time-based cord clamping; Procedure: Physiological-based cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT03808051

NL67770.058.18

Details and patient eligibility

About

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).

Enrollment: 689 patients

Sex: All

Ages: Under 29 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

689 participants in 2 patient groups

Physiological-based cord clamping

Experimental group

Description:

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.

Treatment:

Procedure: Physiological-based cord clamping

Time-based cord clamping

Active Comparator group

Description:

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.

Treatment:

Procedure: Time-based cord clamping