To test whether stabilisation of preterm infants with PBCC using the Concord is at least as effective when compared to the standard approach using the standard resuscitation table.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the time needed to stabilise the infant, starting
from birth. Stable is 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
- Apgar scores
- 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
- Parental satisfaction of the procedure
- Mutiple short term clinical outcomes
Background summary
Most preterm infants fail to aerate their immature lungs at birth and need
respiratory support for stabilisation. Cord clamping before lung aeration then
compromises cardiovascular function. Delaying cord clamping (DCC) until the
lung has aerated is beneficial for preterm infants for a more stable
hemodynamic transition and also for placental transfusion. Until recently, this
was impractical to do, but a new resuscitation table (the Concord) has been
designed to make it possible in preterm infants to keep the cord intact until
the lung has aerated and the infant is respiratory stable and breathing
(Physiological Based Cord Clamping (PBCC)). Feasibility of PBCC with the
Concord has been tested in ABC study 1. Before a large RCT can be planned with
important clinical outcome we wish to test the hypothesis whether stabilizing
preterm infants using PBCC is at least as effective as the standard approach.
Study objective
To test whether stabilisation of preterm infants with PBCC using the Concord is
at least as effective when compared to the standard approach using the standard
resuscitation table.
Study design
Multicenter randomized controlled non-inferiority trial.
Intervention
Preterm infants will be stabilized using the Concord according to PBCC.
Study burden and risks
Stabilisation of preterm infants with the resuscitation table as close as
possible to the mother has been performed before and is considered as safe. We
perform a similar method, but improved the approach by 1) taking into
consideration that stretching of the umbilical cord is prevented, 2) full
standard care for stabilization can be provided and 3) extended monitoring by
including respiratory function monitoring. We do not expect that PBCC opposes
extra risk to the risks related to the stabilisation of the preterm infant.
Nevertheless, we have included several *safety parameters* as secondary
outcomes. The two most important safety parameters are maternal blood loss and
admission temperature of the infant at the NICU. As mentioned before, we did
not find any problems concerning these parameters in our feasibility study.
Furthermore the PBCC approach may increase anxiety in parents, since all
interventions occur close to the parents. By direct communication prenatally
and during stabilisation with the parents about the interventions, this
increased anxiety will be minimised. Parental evaluations in the feasibility
study were merely positive.
Albinusdreef 2 .
Leiden 2300 RC
NL
Albinusdreef 2 .
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Infants born between 24 and 31 weeks of gestational age. Inclusion is possible when no other complications than preterm birth are expected and there are no signs of severe fetal distress. Both, infants born vaginally as well as infants born after caesarean section may be included.
Exclusion criteria
Significant congenital malformations influencing cardiopulmonary transition. Signs of placental abruption or placenta praevia. Emergency caesarean section (ordered to be executed within 15 minutes).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64454.058.18 |
| OMON | NL-OMON19967 |