Prematuriteit, pasgeborenen en ontwikkelingsgerichte zorg Preterm births
Conditions
Interventions
The intervention starts at 30 weeks PMA when infants are born at 29 weeks PMA,
for infants born between 30-33 weeks PMA as soon as possible after admission,
but before 34 weeks.
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Sponsors
Universitair Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: • PMA between 29-33 weeks at birth • PMA between 30-34 weeks at the start of the intervention • Not enrolled in any other intervention study • Parental consent
Exclusion criteria
Exclusion criteria: Invasive mechanical ventilation at the start of the study Severe neurological injuries or severe congenital brain malformation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain maturation as assessed by full EEG (recorded by a neonatal non-invasive, so-called head-cap) and standard care cerebral ultrasound. The main study endpoint will be functional brain maturation as measured by EEG. A 40-minute EEG recording will be made within 24 hours before the start of the first intervention, on day 5 of the intervention period and within 24 hrs after the last intervention. The EEG recordings will be made using the ANT_neuro 'Neo' monitor (used in regular clinical practice) paired with the waveguardtm neonatal caps, which have been used previously by the department and will be used in the future as standard care (CE-approved, developed by ANT Neuro® ). Spontaneous activity transient (SAT) - derived metrics, inter-bust interval (IBI) and burst suppression ratio (BSR) will be computed. SATs will be computed using the in-house SignalBase software*s SAT computation, which is partly based on the algorithm as developed and described by Palmu et al. (2010). IBI and BSR will be computed using the new nëo monitor software developed by ANT Neuro®1 (post-processing). Background pattern, sleep-wake rhythm (none, imminent, normal) and presence/absence of convulsions will be assessed on the corresponding amplitude-integrated EEG trace per the method of classification described in Hellström-Westas, Rosén, Vries & Greisen, 2006). The primary outcome variable will be the average percentage of time detected as SAT-event over the whole of the recording. Furthermore brain maturation will also be assessed using standard ultrasound scans (prior and after the intervention). We will assess Corpus callosum to fastigium distance (Roelants et al 2015). | — |
Secondary
| Measure | Time frame |
|---|---|
| Markers of physiological stability such as heart rate (HR), respiratory rate (RR) and oxygen saturation (SaO2) are continuously monitored as part of the standard care in the NICU and are time-locked recorded using an in-house developed software program called Bedbase. Another program called SignalBase allows post processing of these data. Infant neurobehavior/state of arousal will be assessed before and after the intervention using a behavioral assessments scale (including sleep stages). | — |
Countries
Netherlands
Outcome results
None listed