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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03490721
Enrollment
10
Registered
2018-04-06
Start date
2018-09-12
Completion date
2019-05-30
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Baby 26 to 32 Weeks

Brief 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.

Detailed description

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.

Interventions

OTHERClustering care

During 20 minutes, preterm infants will receive a cluster care with 2 minutes of hand containment.

Sponsors

Université de Montréal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
26 Weeks to 32 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Physiological stability (heart rate, respiratory rate and oxygen saturation)The physiological stability will be measured for 70 minutes.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).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026