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.

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.

Study Overview

• Status: Completed
• Conditions: Premature Baby 26 to 32 Weeks
• Intervention / Treatment: Other: Clustering care

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Université de Montréal
• Investigators: Study Director: Marilyn Aita, PhD, Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2018
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Etude_maitrise_2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The results of this project could be made public in a journal or scientific congress.
• IPD Sharing Time Frame: The results of the study will be available when the study is finished.
• IPD Sharing Access Criteria: The results will be published in a scientific journal.
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No