- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179985
The Impact of Implementing NIDCAP on the Developmental Sensitivity of Nurses Caring for Preterm Infants
July 28, 2011 updated by: Ann & Robert H Lurie Children's Hospital of Chicago
The Impact of Implementing The Newborn Individualized Developmental Care & Assessment Program on the Developmental Sensitivity of Nurses Caring for Preterm Infants
The purpose of this study is to determine whether implementing the Newborn Individualized Developmental Care and Assessment Program increases NICU nurses' sensitivity in meeting the developmental care needs of preterm infants.
Study Overview
Status
Completed
Conditions
Detailed Description
Therapies that have brought about sharp decreases in neonatal mortality have not brought about similar decreases in neurodevelopmental morbidity for preterm infants.
Developmentally supportive care is NICU (Neonatal Intensive Care Unit) care that seeks to optimize the developmental course and outcomes for preterm infants.
In controlled trials, implementation of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) has been associated with with positive medical and neurobehavioral outcomes.
The purpose of this study is to examine the impact of implementing the NIDCAP on the developmental sensitivity of nurses caring for preterm infants in a tertiary level NICU in a children's hospital in the midwest.
The NIDCAP program consists of 1) structured behavioral observations which are conducted at regular intervals during the preterm infant's hospitalization, 2) written plans which outline specific, individualized interventions to address the infant's unique developmental needs which are updated following each observation, and 3) consultations with the infant's caregivers to articulate the infant's current needs and plan.
A convenience sample of 32 NICU nurses will be observed during a routine caregiving episode with one preterm infant before and another preterm infant after the implementation of the NIDCAP program with preterm infants in the NICU.
Following the observations, the nurse's developmental sensitivity will be scored using a standardized tool.
The nurses' developmental sensitivity before the implementation of the NIDCAP program will be compared with their developmental sensitivity following NIDCAP implementation.
Informed consent will be obtained from the nurses participating in the study.
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60148
- Neonatal Intensive Care Unit, Children's Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
NICU Nurse
Description
Inclusion Criteria:
- be an RN,
- be an employee of the NICU at the study site,
- have completed the NICU nursing orientation at the study site,
- work at least 0.4 FTE in the NICU at the study site, and
- be observed while caring for a preterm infant born at less than or equal to 36 weeks gestation and at less than or equal to 1500 grams
Exclusion Criteria:
- Nurses will not be observed while caring for fullterm infants or preterm infants receiving heavy sedation or paralyzing medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Training
Behavioral: Newborn Individualized Care and Assessment Program (NIDCAP)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-NIDCAP implementation and post-NIDCAP implementation, score on a tool designed to measure NICU nurses' developmental sensitivity.
Time Frame: Two years
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Measure NICU nurses' developmental sensitivity after training program
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Two years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan M Horner, RNC, MS, Ann & Robert H Lurie Children's hospital of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
July 29, 2011
Last Update Submitted That Met QC Criteria
July 28, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#2005-12423
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.