Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179933
Status:
TERMINATED
Last Update Posted:
2010-10-11
First Post:
2005-09-14
Brief Title:
The Impact of Implementing NIDCAP on Preterm Infants in the NICU
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
The Impact of Implementing the Newborn Individualized Developmental Care and Assessment Program on Neurobehavioral Organization of Preterm Infants in the NICU
Status:
TERMINATED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to fulfill intention of study lost investigators
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Childrens 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 infants physical environment and caregiving and an assessment of the infants 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
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 Childrens 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 infants physical environment and caregiving and an assessment of the infants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None