The Impact of Implementing NIDCAP on Preterm Infants in the NICU

This study has been terminated.
(Unable to fulfill intention of study, lost investigators.)
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00179933
First received: September 14, 2005
Last updated: October 7, 2010
Last verified: October 2010
  Purpose

The purpose of this study is to evaluate the impact of the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU. Behavioral response to routine caregiving will be compared between infants in the pre-NIDCAP group to infants in the post-NIDCAP group. And it is this behavioral response that will be used to evaluate the effectiveness of the NIDCAP program.


Condition Intervention
Infant, Premature
Behavioral: Newborn Individualized Assessment Program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Implementing the Newborn Individualized Developmental Care and Assessment Program on Neurobehavioral Organization of Preterm Infants in the NICU

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Behavioral function score within 72 hours of admission and Behavioral function score at 34-36 weeks gestation. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Environment and caregiving score within 72 hours of admit [ Designated as safety issue: No ]
  • Environment and caregiving score at 34-36 weeks gestation [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2005
Study Completion Date: February 2007
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 care that seeks to optimize the developmental course and outcomes for preterm infants. While other staff training programs for developmentally supportive care exist, it is the Newborn Developmental Care and Assessment Program (NIDCAP) that has been the methodology used in randomly controlled trials that demonstrate positive medical and neurobehavioral outcomes for preterm infants receiving developmentally supportive care. NICUs that care for all out-born or transported infants face unique challenges in balancing developmentally supportive nursing care with the high-technological medical needs of the most critically ill and extremely premature infants. Yet it is these most fragile infants who can most benefit from the positive impact the NIDCAP program can offer. Yet, there are no published studies documenting the impact of the NIDCAP program on neurobehavioral outcomes of these transported preterm infants exclusively.

Objectives: The objective of this project is to study the impact of implementing the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU of a major pediatric medical center.

Research Methods: A random sample of approximately 40 preterm infants will be recruited to participate in this descriptive study. In this phase-lag design, 20 infants will participate in the pre-NIDCAP intervention phase and 20 infants will participate in the post-NIDCAP intervention phase. Each infant within each phase will be videotaped during 2 routine nurse-caregiving sessions. The first session will occur within 72 hours of admission to the NICU at Children's Memorial Hospital (CMH). The second session will occur when the infant is 34-36 weeks corrected gestational age. The videotapes will be collected so that observations of the infant's physical environment and caregiving and an assessment of the infant's behavioral function can be scored randomly at the end of the study by an outside consultant without bias as to what phase the infant participated. In addition, demographic data will be collected on the sample infants. Data will be subjected to descriptive statistics, inferential statistics and correlational procedures.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infants born at less than or equal to 32 weeks gestation, appropriate for gestational age in weight

Exclusion Criteria:

  • congenital or chromosomal abnormality, history of maternal substance abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179933

Locations
United States, Illinois
Neonatal Intensive Care Unit Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Barbara A Fleming, RNC, MS Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Barbara Fleming, RN, MSN / Clinical Nurse Specialist-NICU, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179933     History of Changes
Other Study ID Numbers: 2005-12574
Study First Received: September 14, 2005
Last Updated: October 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
developmental care
Neonatal Intensive Care Unit

ClinicalTrials.gov processed this record on September 18, 2014