Extrait

Background and study aims The adaptation that all infants are required to make upon entering life outside of the womb is complex. Many physiological changes have to take place for the newborn to survive outside their mother’s womb once she has taken her first few breaths. Approximately 10% of all infants will require some help to make this adaptation. When an infant requires resuscitation, the heart rate is a factor that helps in determining what treatments (or interventions) may be needed. Although the use of non-invasive electrocardiography (ECG) monitoring is a standard of care in the neonatal intensive care unit (NICU), it's use is less well studied in the delivery room. Therefore, we hope to perform ECG monitoring in the delivery room on all infants included in this study. In some cases, the lungs of an infant may need assistance in making the transition to life outside of the womb and interventions such as positive pressure ventilation (PPV) may need to be made. PPV involves a member of the medical team placing a facemask around the infant's face and nose and providing gentle pressure to inflate the lungs, simulating the way an infant would inhale and exhale by themselves. Correct positioning of the infant's airway as well as an airway clear of obstructions are extremely important in making sure that the PPV an infant receives will be effective. At times, this intervention may be difficult to monitor, especially when the infant is small, such as when delivered at less than 32 weeks gestation. An indication of correct positioning of the airway, as well as an unobstructed airway, may be aided through the monitoring of end tidal carbon dioxide (EtCO2) that is produced by the infant when they exhale. This EtCO2 production can be monitored both qualitatively, as well as quantitatively, by means of two different non-invasive devices that are connected to the top of the face mask that is placed on the infant. This trial hopes to investigate both these devices and, in order to complete this investigation as effectively as possible, the device that each infant receives during their time in the delivery room will be randomised. Who can participate? Newborn infants of less than 32 weeks gestation. What does the study involve? Participants are randomly allocated into one of two groups. Those in group 1 receive qualitative, in the form of a disposable end tidal carbon dioxide, (EtCO2) monitoring during resuscitation.Those in group 2 receive quantitative, in the form of side stream capnography, EtCO2 monitoring during resuscitation. All necessary EtCO2 equipment, is made available to the resuscitation team prior to delivery. All infants in both groups have their heart rate monitored by ECG. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? Cork University Maternity Hospital (Ireland). When is the study starting and how long is it expected to run for? August 2014 to June 2015. Who is funding the study? investigator initiated and funded (Ireland). Who is the main contact? Professor Eugene Dempsey.

Critère d'inclusion

• Preterm Birth

Liens

• isrctn
• ictrp