Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368043
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2006-08-23
Brief Title:
Endocrine and Psychological Evaluation of Adopted Children
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biobehavioral Study of Recently Adopted Children
Status:
TERMINATED
Status Verified Date:
2015-03-30
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:
The deleterious effects of institutionalized care on the health and growth and development of children have been described Early studies have shown that the effects of institutionalized care on a childs growth and development may not be fully reversible The exact mechanism through which these early stresses affect bio-behavioral outcomes has yet to be determined A likely mechanism in which environmental influences could regulate both biological and psychosocial development may be through the hypothalamic pituitary adrenal axis HPA Recent advances in the area of brain research have enriched our understanding of the importance of early life experiences on physical cognitive developmental mental and behavioral health outcomes Children adopted from orphanages in countries as diverse as the former Soviet Union and Guatemala provide an opportunity to learn more about the effect of deprivation on neuro-endocrine function physical growth and developmental outcomes including cognitive and behavioral measures
This protocol proposes to study the changes of the HPA axis of the post-institutionalized adoptive child ages 10 months to 4 years which may help elucidate the etiology of the complex findings in this population We will recruit 60 adopted children who experienced institutionalized care and were recently adopted by a US family and 60 controls Our primary hypothesis is that a number of adopted children will have biochemical evidence of stress-induced activation of the HPA axis and sympathetic adrenal medullary system HPA dysfunction will be evident by abnormal diurnal salivary cortisol levels increased cortisol andor catecholamine excretion in 24 hours urine measurements and dysregulation of autonomic nervous system activity We also hypothesize that many of these responses will not normalize with time and that there will be a correlation between these responses and growth and behavioral disorders In addition we will examine nutritional intake and sleep patterns to determine their effect on growth and developmental outcome
This protocol proposes to study the changes of the HPA axis of the post-institutionalized adoptive child ages 10 months to 4 years which may help elucidate the etiology of the complex findings in this population We will recruit 60 adopted children who experienced institutionalized care and were recently adopted by a US family and 60 controls Our primary hypothesis is that a number of adopted children will have biochemical evidence of stress-induced activation of the HPA axis and sympathetic adrenal medullary system HPA dysfunction will be evident by abnormal diurnal salivary cortisol levels increased cortisol andor catecholamine excretion in 24 hours urine measurements and dysregulation of autonomic nervous system activity We also hypothesize that many of these responses will not normalize with time and that there will be a correlation between these responses and growth and behavioral disorders In addition we will examine nutritional intake and sleep patterns to determine their effect on growth and developmental outcome
Detailed Description:
The deleterious effects of institutionalized care on the health and growth and development of children have been described Early studies have shown that the effects of institutionalized care on a childs growth and development may not be fully reversible The exact mechanism through which these early stresses affect bio-behavioral outcomes has yet to be determined A likely mechanism in which environmental influences could regulate both biological and psychosocial development may be through the hypothalamic pituitary adrenal axis HPA Recent advances in the area of brain research have enriched our understanding of the importance of early life experiences on physical cognitive developmental mental and behavioral health outcomes Children adopted from orphanages in countries as diverse as the former Soviet Union and Guatemala provide an opportunity to learn more about the effect of deprivation on neuro-endocrine function physical growth and developmental outcomes including cognitive and behavioral measures
This protocol proposes to study the changes of the HPA axis of the post-institutionalized adoptive child ages 10 months to 4 years which may help elucidate the etiology of the complex findings in this population We will recruit 60 adopted children who experienced institutionalized care and were recently adopted by a US family and 60 controls Our primary hypothesis is that a number of adopted children will have biochemical evidence of stress-induced activation of the HPA axis and sympathetic adrenal medullary system HPA dysfunction will be evident by abnormal diurnal salivary cortisol levels increased cortisol andor catecholamine excretion in 24 hours urine measurements and dysregulation of autonomic nervous system activity We also hypothesize that many of these responses will not normalize with time and that there will be a correlation between these responses and growth and behavioral disorders In addition we will examine nutritional intake and sleep patterns to determine their effect on growth and developmental outcome
This protocol proposes to study the changes of the HPA axis of the post-institutionalized adoptive child ages 10 months to 4 years which may help elucidate the etiology of the complex findings in this population We will recruit 60 adopted children who experienced institutionalized care and were recently adopted by a US family and 60 controls Our primary hypothesis is that a number of adopted children will have biochemical evidence of stress-induced activation of the HPA axis and sympathetic adrenal medullary system HPA dysfunction will be evident by abnormal diurnal salivary cortisol levels increased cortisol andor catecholamine excretion in 24 hours urine measurements and dysregulation of autonomic nervous system activity We also hypothesize that many of these responses will not normalize with time and that there will be a correlation between these responses and growth and behavioral disorders In addition we will examine nutritional intake and sleep patterns to determine their effect on growth and developmental outcome
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-CH-0223 | None | None | None |