Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166660
Status:
UNKNOWN
Last Update Posted:
2009-04-03
First Post:
2005-09-09
Brief Title:
Preterm Fetal Growth Restriction and Developmental Care
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:
Preterm Fetal Growth Restriction and Developmental Care
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
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:
The goal of the project is to show the effectiveness of individualized developmental care and intervention which begins with the FGR preterm infants admission to the newborn intensive care unit NICU and extends to 2 weeks w after full term equivalent age or 2w CA corrected age for prematurity
Detailed Description:
The protocol aims to demonstrate the effectiveness of an intervention geared to significantly improve functional competence for preterm infants with fetal growth restriction FGR Incidence of FGR is estimated to be as high as 5 of the general obstetric population Preterms with FGR are doubly jeopardized Aside from much higher mortality rates they also show significantly increased morbidity rates including significant learning disabilities and school failure 50 The interventions underlying premise holds that it is far more effective to support the immature brain which is compromised by FGR to develop optimally before the infant reaches full term rather than to attempt to ameliorate increasingly deviant development after deviance has occurred The goal of the project is to show the effectiveness of individualized developmental care and intervention which begins with the FGR preterm infants admission to the newborn intensive care unit NICU and extends to 2 weeks w after full term equivalent age or 2w CA corrected age for prematurity Intervention in the NICU is considered more advantageous for the infants later development than delay of intervention until after discharge home The proposal maintains that the last trimester of gestation is a critical period for brain development especially when compromised by FGR In-NICU intervention at this critical brain development time is expected to reduce the infants hypersensitivity and reactivity while in the NICU and to lead to reduction of the high incidence of behavioral problems in infancy which frequently foreshadows later behavioral and learning problems as well as school failure
The study aims to test three related hypotheses
1 Individualized developmental NICU care and intervention will enhance FGR preterm infants brain development both functionally and structurally
2 The in-NICU intervention will improve the parents understanding of their infants individuality and equip them to feel more competent as parents
3 The intervention itself while individualized for each infant will be quantifiable and reliably reproducible
The study will
1 Test the effectiveness of the intervention by assessing brain development and functional adaptation of a high risk preterm population n30 with documented intrauterine FGR and born between 28 and 33w gestational age
2 Assess the FGR preterm infants neurodevelopment within one week from birth baseline and again at 2w CA outcome
3 Compare the results on the effectiveness of the intervention for the FGR preterm infants to a recently studied cohort of appropriately grown AGA preterm infants born at comparable gestational ages supported with the same intervention and measured in comparable ways
The primary infant measures proposed will be brain functional EEG coherence neurobehavioral functioning and brain structural assessments MRI The goal will be to examine the direct causal connections and correlations among population characteristics the intervention and ultimate outcome at 2w CA The project is expected to deliver comprehensive and substantive results in favor of the developmental NICU intervention for FGR preterm infants as well as for the earlier studied AGA population The proposed study is expected to demonstrate intervention effectiveness in improving FGR preterm infants neurodevelopment It is anticipated that the intervention-based improvement in brain structure and function will set the stage for improvement in later performance especially in terms of behavioralemotional adaptation learning and school achievement which are all critical for life success
The study aims to test three related hypotheses
1 Individualized developmental NICU care and intervention will enhance FGR preterm infants brain development both functionally and structurally
2 The in-NICU intervention will improve the parents understanding of their infants individuality and equip them to feel more competent as parents
3 The intervention itself while individualized for each infant will be quantifiable and reliably reproducible
The study will
1 Test the effectiveness of the intervention by assessing brain development and functional adaptation of a high risk preterm population n30 with documented intrauterine FGR and born between 28 and 33w gestational age
2 Assess the FGR preterm infants neurodevelopment within one week from birth baseline and again at 2w CA outcome
3 Compare the results on the effectiveness of the intervention for the FGR preterm infants to a recently studied cohort of appropriately grown AGA preterm infants born at comparable gestational ages supported with the same intervention and measured in comparable ways
The primary infant measures proposed will be brain functional EEG coherence neurobehavioral functioning and brain structural assessments MRI The goal will be to examine the direct causal connections and correlations among population characteristics the intervention and ultimate outcome at 2w CA The project is expected to deliver comprehensive and substantive results in favor of the developmental NICU intervention for FGR preterm infants as well as for the earlier studied AGA population The proposed study is expected to demonstrate intervention effectiveness in improving FGR preterm infants neurodevelopment It is anticipated that the intervention-based improvement in brain structure and function will set the stage for improvement in later performance especially in terms of behavioralemotional adaptation learning and school achievement which are all critical for life success
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