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

NCT03490721 | Completed

• 1 other identifier: Etude_maitrise_2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Baby 26 to 32 Weeks

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Intervention

EXPERIMENTAL

Clustering care for 20 minutes.

Other: Clustering care

Control

NO INTERVENTION

Standard care non clustered.

Interventions

Clustering care OTHER

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

Intervention

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Study Officials

• Marilyn Aita, PhD

  Université de Montréal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 6, 2018
• Study Start: September 12, 2018
• Primary Completion: April 3, 2019
• Study Completion: May 30, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The results of the study will be available when the study is finished.
• Access Criteria: The results will be published in a scientific journal.

Locations

CA (1)