Effects of Clustering Care on the Physiological Stability of Preterm Infants.

Study Overview
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Brief Summary
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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.

Detailed Description
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The cluster care will take place at the time of feeding of the premature infants. The intervention will start with a calm period of 20 minutes before the start of care (no manipulations will be allowed), the baby will then received the cluster care for 20 minutes and a quiet period of 30 minutes will follow after the cluster care.

Official Title
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Effects of Clustering Care on the Physiological Stability of Preterm Infants in a Neonatal Intensive Care Unit.

Conditions
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Premature Baby 26 to 32 Weeks

Intervention / Treatment
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* Other: Clustering care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Clustering care for 20 minutes. | Other: Clustering care<br>* During 20 minutes, preterm infants will receive a cluster care with 2 minutes of hand containment.<br>|
| No Intervention: Control<br>Standard care non clustered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological stability (heart rate, respiratory rate and oxygen saturation) | The physiological stability will be measured with the SCRIP score. The Stability of the cardiorespiratory system in premature infants is a scale, in which a score of 0 means major physiological instability and a score of 6 means a physiological stability. For every single parameter there's three grades from severe instability (0 points) to minor instability (1 point) to perfect stability (2 points). | The physiological stability will be measured for 70 minutes. |