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

NCT ID: NCT03490721

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-12
• Study Completion Date: 2019-05-30

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.

Conditions

Premature Baby 26 to 32 Weeks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention

Clustering care for 20 minutes.

Group Type: EXPERIMENTAL

Clustering care

Intervention Type: OTHER

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

Control

Standard care non clustered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clustering care

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Abril Nicole Fernandez Oviedo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marilyn Aita, PhD

Role: STUDY_DIRECTOR

Université de Montréal

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

Etude_maitrise_2018

Identifier Type: -

Identifier Source: org_study_id