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The Impact of Implementing NIDCAP on the Developmental Sensitivity of Nurses Caring for Preterm Infants
This study is ongoing, but not recruiting participants.
Sponsored by: Children's Memorial Hospital
Information provided by: Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179985
  Purpose

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.


Condition Intervention
Infant, Premature
Behavioral: Newborn Individualized Care and Assessment Program (NIDCAP)

U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: The Impact of Implementing The Newborn Individualized Developmental Care & Assessment Program on the Developmental Sensitivity of Nurses Caring for Preterm Infants

Further study details as provided by Children's Memorial Hospital:

Primary Outcome Measures:
  • Pre-NIDCAP implementation and post-NIDCAP implementation, score on a tool designed to measure NICU nurses' developmental sensitivity.

Estimated Enrollment: 32
Study Start Date: December 2004
Estimated Study Completion Date: May 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179985

Locations
United States, Illinois
Neonatal Intensive Care Unit, Children's Memorial Hospital
Chicago, Illinois, United States, 60148
Sponsors and Collaborators
Children's Memorial Hospital
Investigators
Principal Investigator: Susan M Horner, RNC, MS Children's Memorial Hospital
  More Information

Study ID Numbers: IRB#2005-12423
Study First Received: September 14, 2005
Last Updated: October 23, 2006
ClinicalTrials.gov Identifier: NCT00179985  
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Memorial Hospital:
Developmental Care
Neonatal Intensive Care Unit (NICU)

ClinicalTrials.gov processed this record on January 14, 2009