|- candidate number||28833|
|- NTR Number||NTR7194|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-apr-2018|
|- Secondary IDs||NL64454.058.18 METC LUMC|
|- Public Title||Starting respiratory support prior to cord clamping in preterm infants to improve pulmonary en circulatory transition immediately after birth: effectivenss study.|
|- Scientific Title||Stabilisation of preterm infants with intact umbilical cord: effectiveness study.|
|- hypothesis||Stabilisation of preterm infants performing physioloigcal based cord clamping using the Concord is at least as effective as stabilisation according to the standard approach using the standard resusciation table.|
|- Healt Condition(s) or Problem(s) studied||Premature infants, Resuscitation, Cord clamping, Transition|
|- Inclusion criteria||Infants born between 24 and 31 weeks of gestational age and no other complications than preterm birth are expected.|
|- Exclusion criteria||Significant congenital malformations influencing cardiopulmonary transition. |
Signs of placental abruption or placenta praevia.
Signs of severe fetal distress.
Emergency caesarean section (ordered to be executed within 15 minutes).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-apr-2018|
|- planned closingdate||1-jan-2019|
|- Target number of participants||64|
|- Interventions||Preterm infants randomized to the intervention group will be stabilized according to physioloigcal based coord clamping (PBCC). As soon as the infant is born, the infant will be placed on the Concord (a purpose-built resusciation table) and respiratory support will be started according to the local resuscitation guidelines. The umbilical cord will not be clamped until the infant is stabilised, defined as the establishment of regular spontaneous breathing evaluated on the respiratory function monitor, a heart rate °› 100 bpm and oxygen saturation above 90% while using FiO2 < 0.40.|
Preterm infants randomized to the control group will receive delayed cord clamping (DCC) for 30-60 seconds and will be subsequently stabilised according to standard local resusciation guidelines on a regular resuscitation table.
|- Primary outcome||The primary outcome will be the time needed to stabilise the infant, starting from birth and defined as the establishment of regular spontaneous breathing evaluated on the respiratory function monitor, a heart rate ≥ 100 bpm and oxygen saturation above 90% while using FiO2 < 0.40. |
|- Secondary outcome||The time point after birth when respiratory support was started and oximeter signals could be interpreted. |
The occurrence the ABC approach could not be performed and reason why.
Failure of reaching the primary outcome within 10 minutes from birth.
Duration of mask ventilation given.
Average pressures given during mask ventilation.
Average pressure given during mask CPAP.
Oxygen saturation and heart rate in the first 10 minutes from birth.
Time point of cord clamping.
Problems occurring with the cord before cord clamping.
Occurrence of the need for cord clamping before stabilisation.
The occurrence of the necessity for intubation in the DR.
The occurrence of hypothermia at admission in the NICU.
Echocardiography measurement: ductal flow ratio at 1 hour of age.
Maternal blood loss.
The occurrence of postpartum haemorrhage.
The occurrence of surgical site wound infection after caesarean section.
|- Timepoints||The intervention is immediately after at birth and restricted to PBCC or regular support of transition. All other clinical care is according to standard local protocols with no difference between the intervention and control group.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Ronny Knol|
|- CONTACT for SCIENTIFIC QUERIES|| Ronny Knol|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|NWO, Sophia Childrenís Hospital Fund, Gisela Thier Fund|
|- Brief summary||Experimental studies have shown that assuring lung aeration and ventilation before cord clamping results in more stable cardiovascular transition at birth. Our newly designed resuscitation table, the Concord, allows to delay cord clamping in preterm infants until the infant is stabilised; an approach considered as Physiological-Based Cord Clamping (PBCC). Feasibility of PBCC with the Concord has been tested and confirmed. In this study our objective is to test whether stabilisation of preterm infants (24 - 31 weeks) performing PBCC using the Concord is at least as effective when compared to the standard approach using the standard resuscitation table. We wil perform a multicenter randomized controlled non-inferiority trial and the primary outcome will be the time needed to stabilize the infant, starting from birth. |
|- Main changes (audit trail)|
|- RECORD||20-apr-2018 - 13-mei-2018|