Aeration, Breathing, Clamping Study 3 (ABC3)
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|ClinicalTrials.gov Identifier: NCT03808051|
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 31, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Preterm Infant Birth, Preterm||Procedure: Physiological-based cord clamping Procedure: Time-based cord clamping||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||660 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Physiological-based Cord Clamping in Very Preterm Infants: a Multicentre Randomised Controlled Trial.|
|Actual Study Start Date :||January 25, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2023|
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.
Procedure: Physiological-based cord clamping
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.
Procedure: Time-based cord clamping
See Arm description.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808051
|Contact: Arjan B Te Pas, Prof||+31 71 email@example.com|
|Contact: Ronny Knol, MD||+31 10 703 60 firstname.lastname@example.org|
|Amsterdam University Medical Centre, location AMC||Recruiting|
|Contact: Anton Van Kaam, Prof|
|Contact: Jeroen Hutten, PhD|
|Amsterdam University Medical Centre, location VU||Recruiting|
|Contact: Sandra Prins, PhD|
|University Medical Centre Groningen||Not yet recruiting|
|Contact: Christian Hulzebos, PhD|
|Leiden University Medical Centre||Recruiting|
|Contact: Arjan B Te Pas, Prof|
|Maastricht University Medical Centre||Not yet recruiting|
|Contact: Boris Kramer, Prof|
|Contact: Maayke Van der Putten, MD|
|Radboud University Medical Centre||Recruiting|
|Contact: Willem P De Boode, Prof|
|Erasmus Medical Centre - Sophia Children's Hospital||Recruiting|
|Contact: Ronny Knol, MD|
|Contact: Irwin KM Reiss, Prof|
|Maxima Medical Centre||Not yet recruiting|
|Contact: Hendrik Niemarkt, PhD|
|Contact: Peter Andriessen, PhD|
|Isala Clinics Zwolle||Not yet recruiting|
|Contact: Estelle EM Mulder, MD|
|Study Chair:||Arjan B Te Pas, Prof||Leiden University Medical Centre|
|Principal Investigator:||Ronny Knol, MD||Erasmus Medical Centre Rotterdam|