Aeration, Breathing, Clamping Study 3

Preterm Infant Clinical Trial

— ABC3  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03808051
• Other study ID #: NL67770.058.18
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 25, 2019
• Est. completion date: May 15, 2025

Study information

• Verified date: May 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 689
• Est. completion date: May 15, 2025
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 29 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Birth, Preterm
• Premature Birth
• Preterm Infant

Intervention

Procedure:
• Physiological-based cord clamping
See Arm description.
• Time-based cord clamping
See Arm description.

Locations

Country	Name	City	State
Netherlands	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

Sponsors (4)

Lead Sponsor	Collaborator
Leiden University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Medical Research Foundation, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental perception and appreciation of stabilisation at birth	Questionnaire sent to parents concerning the perception and appreciation of the approach during birth and the perinatal stabilisation of the infant.	Sent within 1 week after birth.
Primary	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.	From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
Secondary	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.	From birth until one hour of age.
Secondary	Short-term neonatal outcomes	Incidence of prematurity related morbidities during hospital stay.	From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
Secondary	Short-term maternal outcomes	Incidence of postpartum haemorrhage (> 1000 ml) and surgical site infection after caesarean section.	From date of randomization until five days after intervention.
Secondary	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.	Assesment at two years corrected age.
Secondary	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.	Assesment at two years corrected age.
Secondary	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.	Assesment at two years corrected age.