Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aeration, Breathing, Clamping Study 3 (ABC3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808051
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 31, 2020
Sponsor:
Collaborators:
Erasmus Medical Center
Medical Research Foundation, The Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
PasABte, Leiden University Medical Center

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).


Condition or disease Intervention/treatment Phase
Preterm Infant Birth, Preterm Procedure: Physiological-based cord clamping Procedure: Time-based cord clamping Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Arjan B Te Pas, Prof +31 71 5262909 a.b.te_pas@lumc.nl
Contact: Ronny Knol, MD +31 10 703 60 77 r.knol@erasmusmc.nl

Locations
Layout table for location information
Netherlands
Amsterdam University Medical Centre, location AMC Recruiting
Amsterdam, Netherlands
Contact: Anton Van Kaam, Prof         
Contact: Jeroen Hutten, PhD         
Amsterdam University Medical Centre, location VU Recruiting
Amsterdam, Netherlands
Contact: Sandra Prins, PhD         
University Medical Centre Groningen Not yet recruiting
Groningen, Netherlands
Contact: Christian Hulzebos, PhD         
Leiden University Medical Centre Recruiting
Leiden, Netherlands
Contact: Arjan B Te Pas, Prof         
Maastricht University Medical Centre Not yet recruiting
Maastricht, Netherlands
Contact: Boris Kramer, Prof         
Contact: Maayke Van der Putten, MD         
Radboud University Medical Centre Recruiting
Nijmegen, Netherlands
Contact: Willem P De Boode, Prof         
Erasmus Medical Centre - Sophia Children's Hospital Recruiting
Rotterdam, Netherlands
Contact: Ronny Knol, MD         
Contact: Irwin KM Reiss, Prof         
Maxima Medical Centre Not yet recruiting
Veldhoven, Netherlands
Contact: Hendrik Niemarkt, PhD         
Contact: Peter Andriessen, PhD         
Isala Clinics Zwolle Not yet recruiting
Zwolle, Netherlands
Contact: Estelle EM Mulder, MD         
Sponsors and Collaborators
Leiden University Medical Center
Erasmus Medical Center
Medical Research Foundation, The Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Layout table for investigator information
Study Chair: Arjan B Te Pas, Prof Leiden University Medical Centre
Principal Investigator: Ronny Knol, MD Erasmus Medical Centre Rotterdam

Layout table for additonal information
Responsible Party: PasABte, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03808051    
Other Study ID Numbers: NL67770.058.18
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PasABte, Leiden University Medical Center:
Preterm infant
Cord clamping
Resuscitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications