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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490721
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Abril Nicole Fernandez Oviedo, Université de Montréal

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.

Condition or disease Intervention/treatment Phase
Premature Baby 26 to 32 Weeks Other: Clustering care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effects of Clustering Care on the Physiological Stability of Preterm Infants in a Neonatal Intensive Care Unit.
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : May 30, 2019

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.



Primary Outcome Measures :
  1. Physiological stability (heart rate, respiratory rate and oxygen saturation) [ Time Frame: 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).



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Ages Eligible for Study:   26 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490721


Locations
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Canada, Quebec
Jewish General Hospital
Montréal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Université de Montréal
Investigators
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Study Director: Marilyn Aita, PhD Université de Montréal

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Responsible Party: Abril Nicole Fernandez Oviedo, Principal investigator, Université de Montréal
ClinicalTrials.gov Identifier: NCT03490721    
Other Study ID Numbers: Etude_maitrise_2018
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results of this project could be made public in a journal or scientific congress.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No