Recruiting

Observational Study

Sponsor:

McMaster Children's Hospital

Code:

NCT02912780

Conditions

Stress, Psychological

Inflammatory Bowel Diseases

Lung Diseases

Infant Nutrition Disorders

Eye Manifestations

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02912780

Start date

Jan, 2013

Status verified date

Sep, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion criteria:

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

Exclusion criteria:

  • no exclusion criteria

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Christoph Fusch, MD, PhD

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

Locations

Faculty of Health Science, McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Christoph Fusch, MD, PhD

+1 905 521 2100fusch@mcmaster.ca

Principal Investigator:

Christoph Fusch

More Information

Sponsor

McMaster Children's Hospital

Last update posted

Sep 23, 2016

Last verified

Sep, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster Children's Hospital on 2016-09-23.