Effects of Clustering Care on the Physiological Stability of Preterm Infants. (NCT03490721) | Clinical Trial Compass
CompletedNot Applicable
Effects of Clustering Care on the Physiological Stability of Preterm Infants.
Canada10 participantsStarted 2018-09-12
Plain-language summary
This crossover design experimental study aims to compare the physiological stability of premature newborns during and after a cluster of care compared to a period when they receive standard non clustered care at the neonatal unit.
Who can participate
Age range26 Weeks – 32 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* between 26 to 31 6/7 weeks of gestation at birth
* more than 72 hours of life,
* receive a respiratory aid such as endotracheal tube, NIPPV (non invasive positive pressures ventilation), CPAP (continuous positive airway pressure) or nasal prongs with oxygen,
* are fed intravenously (IV) or by central venous catheter (CVC),
* one of the parents speaks and reads English or French,
* one of the parents is at least 18 years old to sign the consent.
Exclusion Criteria:
* severely ill (necrotizing enterocolitis, septicemia),
* under respiratory assistance or on a high frequency mode,
* having a congenital or cardiac abnormality,
* requiring surgery,
* sedatives or opioids,
* diagnosed with grade II, III or IV intraventricular hemorrhage and / or hydrocephalus,
* have a device for invasive blood pressure,
* having an oxygen requirement of more than 30% to maintain oxygen saturation within the limits indicated by the NICU (neonatal intensive care unit).
* one of the parents is at least 18 years old to sign the consent.
What they're measuring
1
Physiological stability (heart rate, respiratory rate and oxygen saturation)
Timeframe: The physiological stability will be measured for 70 minutes.