Stabiliziation of preterm infant with intact umbilical cord: a feasibility study

Rationale:

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 now 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.



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.



Study population: infants of 26-35 weeks of gestation.
Intervention: Preterm infants will be stabilized on the Con-Cord table according to the ABC approach.



Main study parameters/endpoints: 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.

It is safe and feasible to use the Con-Cord table for the ABC approach for stabilisation of preterm infants at birth.

first 10 minutes of life after birth

Preterm infants will be stabilized according to the Aearation, Breathing, then Clamping (ABC) approach. As soon as the infant is born, the infant will be placed on the Con-Cord table and respiratory support will be given according to the local resuscitation guidelines. The umbilical cord will not be clamped until the infant is stabilized and breathing.



With the exception that the infant is stabilized close to the mother and the cord is clamped in a later stage, the infant will receive standard treatment.