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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
689
See Arm description.
See Arm description.
Amsterdam University Medical Centre, location AMC
Amsterdam, Netherlands
Amsterdam University Medical Centre, location VU
Amsterdam, Netherlands
University Medical Centre Groningen
Groningen, Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Radboud University Medical Centre
Nijmegen, Netherlands
Erasmus Medical Centre - Sophia Children's Hospital
Rotterdam, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
Maxima Medical Centre
Veldhoven, Netherlands
Isala Clinics Zwolle
Zwolle, Netherlands
Intact survival at NICU discharge
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.
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.
Rate of treatment failure
Treatment failure defined as the number of participants in which abortion of prescribed procedure (intervention or control) occurred and the reasons for abortion.
Time frame: From birth until one hour of age.
Short-term neonatal outcomes
Incidence of prematurity related morbidities during hospital stay.
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.
Short-term maternal outcomes
Incidence of postpartum haemorrhage (\> 1000 ml) and surgical site infection after caesarean section.
Time frame: From date of randomization until five days after intervention.
Neurodevelopmental outcome (Cognitive) at 2 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.
Time frame: Assesment at two years corrected age.
Neurodevelopmental outcome (Motor) at 2 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.
Time frame: Assesment at two years corrected age.
Functional outcome at 2 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.
Time frame: Assesment at two years corrected age.
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