Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit

NCT02912780 | Unknown

• 1 other identifier: COHORT2013
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Stress, Psychological; Inflammatory Bowel Diseases; Lung Diseases; Infant Nutrition Disorders; Eye Manifestations; Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (17)

• Change of stress level of Health Care Professional - Salivary cortisol (ng/dL)

  once every week, up to 3 month corrected age

• Change of stress level of Parents - Salivary cortisol (ng/dL)

  once every week, up to 3 month corrected age

• Change of stress level of Patients - Salivary cortisol (ng/dL)

  once every week, up to 3 month corrected age

• Length of stay - days

  up to 3 month corrected age

• Incidence of necrotizing enterocolitis

  up to 3 month corrected age

• Incidence of retinopathia of prematurity

  up to 3 month corrected age

• Incidence of bronchopulmonary dysplasia

  up to 3 month corrected age

• Incidence of sepsis

  up to 3 month corrected age

• Duration of mechanical ventilation - days

  up to 3 month corrected age

• Time of feed initiation - days

  up to 3 month corrected age

• Time to full feed - days

  up to 3 month corrected age

• Number of days with parenteral nutrition

  up to 3 month corrected age

• Bayley scale - Psychomotor Developmental Index

  up to 3 month corrected age

• Bayley scale - Mental Developmental Index

  up to 3 month corrected age

• Number of changes in the primary health care professionals

  up to 3 month corrected age

• Noise level (decibel)

  up to 3 month corrected age

• use of resources (lab tests, X-rays, microbiological tests)

  number of procedures

  up to 3 month corrected age

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Preterm and term infants

You may qualify if:

• All preterm and term infants admitted to McMaster Children's Hospital NICU

Sponsors & Collaborators

• McMaster Children's Hospital: lead

Study Sites (1)

Faculty of Health Science, McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 28109276 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Inflammatory Bowel Diseases; Lung Diseases; Infant Nutrition Disorders; Eye Manifestations; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Respiratory Tract Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Christoph Fusch, MD, PhD

CONTACT

+1-905-527-6342; fusch@mcmaster.ca

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 23, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)