Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065364
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-07-21
Brief Title:
Improving Brain Development in Medically Healthy Premature Infants
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Neurodevelopment and Experience Behavior Quantitative EEG and MRI
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Premature infants born between 28 and 33 weeks gestation often have significant brain damage Brain damage can be caused by the much greater stimulation the infant receives in the neonatal intensive care unit NICU as compared to the mothers womb This study will test the effectiveness of specialized and individualized NICU developmental care in preventing brain damage
Detailed Description:
From 28 to 33 weeks gestation significant neurological reorganization takes place initiating fetal behavioral individuality and capacity for extrauterine survival Infants born at this transitional stage exhibit unexpectedly significant brain dysfunction as they develop and age The majority of these infants will develop psychomotor cognitive and attentional function deficits as well as emotional vulnerability and substandard school performance Research suggests that these symptoms are due to a central deficit in frontal lobe processing of complex information This central deficit may result from increased vulnerability of cerebral white matter during the last trimester of gestation its phase of most rapid development Persistent stress due to inappropriate sensory stimulation may contribute to alteration of early brain structure and function This study will identify specific adaptations of the preterm brain to the transient NICU experience in order to estimate the potential of such experience in remodeling neuroanatomical structure and neurodevelopmental function Further the study will evaluate a program of specialized developmental care within the NICU environment
The studys specialized developmental care model views the preterm infant as a fetus and attempts to reduce the discrepancy between the technological hospital environment and the mothers womb A developmental specialist team will support the NICU caregivers The developmental specialists will observe the infants behavior and use these observations to formulate descriptive neurobehavioral reports and suggestions to structure caregiving procedures in coordination with the infants sleepwake cycle and to maintain the infants well-regulated behavioral balance The goal of the intervention is to promote the infants strengths while reducing the infants self-regulatory vulnerability
Sixty medically healthy infants born between 28 and 33 weeks gestation will be randomly assigned to standard NICU care or specialized developmental care Preterm infants will be compared to 30 healthy full term infants All infants will be assessed at 42 weeks postconceptional age in three neurodevelopmental domains neurobehavioral function neuroelectrophysiological function and neuroanatomic structure Assessments will focus on distinct regions of the brain occipital and frontal lobes and the corpus callosum which connects the right and left sides of the brain
The studys specialized developmental care model views the preterm infant as a fetus and attempts to reduce the discrepancy between the technological hospital environment and the mothers womb A developmental specialist team will support the NICU caregivers The developmental specialists will observe the infants behavior and use these observations to formulate descriptive neurobehavioral reports and suggestions to structure caregiving procedures in coordination with the infants sleepwake cycle and to maintain the infants well-regulated behavioral balance The goal of the intervention is to promote the infants strengths while reducing the infants self-regulatory vulnerability
Sixty medically healthy infants born between 28 and 33 weeks gestation will be randomly assigned to standard NICU care or specialized developmental care Preterm infants will be compared to 30 healthy full term infants All infants will be assessed at 42 weeks postconceptional age in three neurodevelopmental domains neurobehavioral function neuroelectrophysiological function and neuroanatomic structure Assessments will focus on distinct regions of the brain occipital and frontal lobes and the corpus callosum which connects the right and left sides of the brain
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