Stress, PsychologicalNCT02912780
Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit
An observational study of Stress, Psychological and Inflammatory Bowel Diseases, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
The advancement in life-saving technologies and clinical expertise in the care of extremely premature infants, have resulted in the development of large neonatal intensive care units (NICU). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress, Psychological, Inflammatory Bowel Diseases, Lung Diseases
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm and term infants
Who may be able to join
- All preterm and term infants admitted to McMaster Children's Hospital NICU
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Faculty of Health Science, McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Christoph Fusch, MD, PhD, +1 905 521 2100 ext. 75721, fusch@mcmaster.ca
Christoph Fusch
About this study
Official title: Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit - an Interprofessional Approach
The advancement in life-saving technologies and clinical expertise in the care of extremely premature infants, have resulted in the development of large neonatal intensive care units (NICU). It has been suggested that reconstruction of megaunits of neonatal intensive care to smaller care units with specific patient population and clinical team providers will be essential to maintain optimal teamwork, quality of care and patient outcome.
Despite the growing knowledge around the need for reconstruction of large NICUs to smaller units of care, there is no evidence regarding the safety and efficacy of microsystem model of care on the key aspects of health care. At the McMaster Children's Hospital (MCH), we planned a change from standard model of care to the microsystem model of care and therefore we aimed to prospectively assess the effect of this organizational change on the variable aspects of health care.
Read more
A working group met weekly to formulate the implementation planning, to review the adaptation and adjustment process and to ascertain the quality of implementation following the initiation of the microsystem model.
The study was retrospectively registered.
- Conditions
- Stress, Psychological, Inflammatory Bowel Diseases, Lung Diseases, Infant Nutrition Disorders, Eye Manifestations, Neurodevelopmental Disorders
- Medical subject headings
- Stress, Psychological, Inflammatory Bowel Diseases, Lung Diseases, Infant Nutrition Disorders, Eye Manifestations, Neurodevelopmental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of stress level of Health Care Professional - Salivary cortisol (ng/dL)
Measured: once every week, up to 3 month corrected age
Change of stress level of Parents - Salivary cortisol (ng/dL)
Measured: once every week, up to 3 month corrected age
Change of stress level of Patients - Salivary cortisol (ng/dL)
Measured: once every week, up to 3 month corrected age
Length of stay - days
Measured: up to 3 month corrected age
Incidence of necrotizing enterocolitis
Measured: up to 3 month corrected age
Incidence of retinopathia of prematurity
Measured: up to 3 month corrected age
Incidence of bronchopulmonary dysplasia
Measured: up to 3 month corrected age
Incidence of sepsis
Measured: up to 3 month corrected age
Duration of mechanical ventilation - days
Measured: up to 3 month corrected age
Time of feed initiation - days
Measured: up to 3 month corrected age
Time to full feed - days
Measured: up to 3 month corrected age
Number of days with parenteral nutrition
Measured: up to 3 month corrected age
Bayley scale - Psychomotor Developmental Index
Measured: up to 3 month corrected age
Bayley scale - Mental Developmental Index
Measured: up to 3 month corrected age
Number of changes in the primary health care professionals
Measured: up to 3 month corrected age
Noise level (decibel)
Measured: up to 3 month corrected age
use of resources (lab tests, X-rays, microbiological tests)
number of procedures
Measured: up to 3 month corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Fusch, McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912780
- Sponsor's protocol ID
- COHORT2013
- Status last verified
- Sep 2016
- First submitted
- 14 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
El Helou S, Samiee-Zafarghandy S, Fusch G, Wahab MG, Aliberti L, Bakry A, Barnard D, Doucette J, El Gouhary E, Marrin M, Meyer CL, Mukerji A, Nwebube A, Pogorzelski D, Pugh E, Schattauer K, Shah J, Shivananda S, Thomas S, Twiss J, Williams C, Dutta S, Fusch C. Introduction of microsystems in a level 3 neonatal intensive care unit-an interprofessional approach. BMC Health Serv Res. 2017 Jan 21;17(1):61. doi: 10.1186/s12913-017-1989-6.
PubMed 28109276
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit - an Interprofessional Approach
- ClinicalTrials.gov ID
- NCT02912780
- Acronym / sponsor ID
- COHORT2013
- Conditions
- Stress, Psychological, Inflammatory Bowel Diseases, Lung Diseases, Infant Nutrition Disorders, Eye Manifestations, Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The advancement in life-saving technologies and clinical expertise in the care of extremely premature infants, have resulted in the development of large neonatal intensive care units (NICU). It has been suggested that reconstruction of megaunits of neonatal intensive care to smaller care units with specific patient population and clinical team providers will be essential to maintain optimal teamwork, quality of care and patient outcome.
Despite the growing knowledge around the need for reconstruction of large NICUs to smaller units of care, there is no evidence regarding the safety and efficacy of microsystem model of care on the key aspects of health care. At the McMaster Children's Hospital (MCH), we planned a change from standard model of care to the microsystem model of care and therefore we aimed to prospectively assess the effect of this organizational change on the variable aspects of health care.
A working group met weekly to formulate the implementation planning, to review the adaptation and adjustment process and to ascertain the quality of implementation following the initiation of the microsystem model.
The study was retrospectively registered.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm and term infants
Key inclusion criteria (1 listed)
- All preterm and term infants admitted to McMaster Children's Hospital NICU
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of stress level of Health Care Professional - Salivary cortisol (ng/dL)
Time frame: once every week, up to 3 month corrected age
Change of stress level of Parents - Salivary cortisol (ng/dL)
Time frame: once every week, up to 3 month corrected age
Change of stress level of Patients - Salivary cortisol (ng/dL)
Time frame: once every week, up to 3 month corrected age
Length of stay - days
Time frame: up to 3 month corrected age
Incidence of necrotizing enterocolitis
Time frame: up to 3 month corrected age
Incidence of retinopathia of prematurity
Time frame: up to 3 month corrected age
Incidence of bronchopulmonary dysplasia
Time frame: up to 3 month corrected age
Incidence of sepsis
Time frame: up to 3 month corrected age
Duration of mechanical ventilation - days
Time frame: up to 3 month corrected age
Time of feed initiation - days
Time frame: up to 3 month corrected age
Time to full feed - days
Time frame: up to 3 month corrected age
Number of days with parenteral nutrition
Time frame: up to 3 month corrected age
Bayley scale - Psychomotor Developmental Index
Time frame: up to 3 month corrected age
Bayley scale - Mental Developmental Index
Time frame: up to 3 month corrected age
Number of changes in the primary health care professionals
Time frame: up to 3 month corrected age
Noise level (decibel)
Time frame: up to 3 month corrected age
use of resources (lab tests, X-rays, microbiological tests)
Time frame: up to 3 month corrected age
number of procedures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Derived from this study: PubMed 28109276El Helou S, Samiee-Zafarghandy S, Fusch G, Wahab MG, Aliberti L, Bakry A, Barnard D, Doucette J, El Gouhary E, Marrin M, Meyer CL, Mukerji A, Nwebube A, Pogorzelski D, Pugh E, Schattauer K, Shah J, Shivananda S, Thomas S, Twiss J, Williams C, Dutta S, Fusch C. Introduction of microsystems in a level 3 neonatal intensive care unit-an interprofessional approach. BMC Health Serv Res. 2017 Jan 21;17(1):61. doi: 10.1186/s12913-017-1989-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological and Inflammatory Bowel Diseases, run by McMaster Children's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Fusch, MD, PhD (+1-905-527-6342, fusch@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of stress level of Health Care Professional - Salivary cortisol (ng/dL) (time frame: once every week, up to 3 month corrected age). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02912780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.