Aeration, Breathing, Clamping Study 3

Conditions

Birth, Preterm, Preterm Infant

Keywords

Preterm infant, Cord clamping, Resuscitation

Brief 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).

Knol R, Brouwer E, van den Akker T, DeKoninck PLJ, Onland W, Vermeulen MJ, de Boode WP, van Kaam AH, Lopriore E, Reiss IKM, Hutten GJ, Prins SA, Mulder EEM, d'Haens EJ, Hulzebos CV, Bouma HA, van Sambeeck SJ, Niemarkt HJ, van der Putten ME, Lebon T, Zonnenberg IA, Nuytemans DH, Willemsen SP, Polglase GR, Steggerda SJ, Hooper SB, Te Pas AB.

2024-12-0412 citations

10.1016/j.lanepe.2024.101146

Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-statistical analysis plan for a multicenter randomized controlled trial.

Willemsen SP, Knol R, Brouwer E, van den Akker T, DeKoninck PLJ, Lopriore E, Onland W, de Boode WP, van Kaam AH, Nuytemans DH, Reiss IKM, Hutten GJ, Prins SA, Mulder EEM, Hulzebos CV, van Sambeeck SJ, van der Putten ME, Zonnenberg IA, Te Pas AB, Vermeulen MJ.

2024-03-043 citations

10.1186/s13063-024-08014-y

Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-study protocol for a multicentre randomised controlled trial.

Knol R, Brouwer E, van den Akker T, DeKoninck PLJ, Lopriore E, Onland W, Vermeulen MJ, van den Akker-van Marle ME, van Bodegom-Vos L, de Boode WP, van Kaam AH, Reiss IKM, Polglase GR, Hutten GJ, Prins SA, Mulder EEM, Hulzebos CV, van Sambeeck SJ, van der Putten ME, Zonnenberg IA, Hooper SB, Te Pas AB.

2022-10-0115 citations

10.1186/s13063-022-06789-6

Interventions

PROCEDUREPhysiological-based cord clamping

See Arm description.

PROCEDURETime-based cord clamping

See Arm description.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 29 Weeks

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Intact survival at NICU discharge	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

Measure	Time frame	Description
Short-term neonatal outcomes	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	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	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.
Rate of treatment failure	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.
Functional outcome at 2 years corrected age	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.
Neurodevelopmental outcome (Motor) at 2 years corrected age	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.

Other

Measure	Time frame	Description
Parental perception and appreciation of stabilisation at birth	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.

Countries

Netherlands

Outcome results

None listed