To test the safety of using the Con-Cord table for stabilization of preterm infants according to the ABC approach.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
safety and feasibility measures. Primary outcome will be the success in
supporting preterm infants according to local guidelines while the umbilical
cord is intact and not stretched)
Secondary outcome
NA
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 until the lung has
aerated is beneficial for preterm infants for a more stable hemodynamic
transition and also placental transfusion, for which breathing is an important
driving force. Until this was impractical to do, but a resuscitation table (the
Con-Cord table) 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 (the Aeration Breathing Clamping (ABC) approach).
Before a large RCT can be planned with important clinical outcome we need to
test the safety and effectiveness of the new medical device (Con-Cord table)
and the ABC approach. Three consecutive studies will be performed: 1)
feasibility study, 2) effectiveness study and 3) clinical randomized trial.
This is part one of the project: the feasibility study.
Study objective
To test the safety of using the Con-Cord table for stabilization of preterm
infants according to the ABC approach.
Study design
a feasibility study
Intervention
Preterm infants will be stabilized on the according to the ABC approach
Study burden and risks
Using the Con-Cord table that is designed to perform the ABC approach while all
care can be provided that is similar to a standard resuscitation table and we
expect no additional burden or risk next to prematurity related risk. There is
also no extra risk to keeping the cord intact until the infant is stabilized.
There are potential benefits, but a larger RCT is needed to confirm this.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Infants of 26-34 weeks gestational age and 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. A minimum of 5 infants born by caeserean section will be included.
Exclusion criteria
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
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL57810.058.16 |