Effects of Clustering Care on the Physiological Stability... | NCT03490721

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

NCT03490721

Sponsor

Université de Montréal

Status

Completed

Last Update Posted

Jan 18, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Premature Baby 26 to 32 Weeks

Interventions

Clustering care

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2018Actual

Primary Completion Date

Apr 3, 2019Actual

Completion Date

May 30, 2019Actual

First Submitted Date

Mar 23, 2018

First Submission Date that Met QC Criteria

Apr 5, 2018

First Posted Date

Apr 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2020

Last Update Posted Date

Jan 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Clustering care for 20 minutes.	Other: Clustering care
Control	No Intervention	Standard care non clustered.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clustering care	Other	During 20 minutes, preterm infants will receive a cluster care with 2 minutes of hand containment.	Intervention

Outcomes Module

Primary Outcomes

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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Weeks

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Marilyn Aita, PhD	Université de Montréal	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Jewish General Hospital		Montreal	Quebec	H3T1E2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The results of this project could be made public in a journal or scientific congress.

Types

Clinical Study Report (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.

URL

Not provided