Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009633
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2001-02-01
Brief Title:
Follow-up Visit of High Risk Infants
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Follow-up Visit of High Risk Infants
Status:
RECRUITING
Status Verified Date:
2023-03
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:
FU
Brief Summary:
The NICHD Neonatal Research Networks Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental neurosensory and functional assessments at 22-26 months corrected age Infants born prior to July 1 2012 were seen at 18-22 months corrected age Data regarding pregnancy and neonatal outcome are collected prospectively The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment
Detailed Description:
The NICHD Neonatal Research Networks Follow-Up study is a multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental neurosensory and functional assessments at 22-26 months corrected age Infants born prior to July 1 2012 were seen at 18-22 month corrected age The goal of the study is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment including
Evaluating development of motor skills cognitive skills language and behavior
Determining mortality and the prevalence of specific medical conditions
Assessing the relationship between growth and neurodevelopmental outcome
Assessing the relationship between the socioeconomic status and developmental outcome
Assessing the use of special support services and early intervention programs by this population
Evaluating the need for follow-up at school age
The scheduled evaluations collect demographic information socioeconomic status medical history medications medical equipment required growth data a detailed neurologic examination Bayley Scales of Infant Development mental motor infant behavior Child Behavior Checklist
A sub-study will assess a reference group comprised of a limited number of healthy term infants born in Network centers to meet the following three aims 1 to avoid potential ascertainment biases due to examiner expectations when only extremely preterm or other high-risk infants are assessed 2 in the absence of well-developed norms for the Bayley Scales to define thresholds for impairment based on data for a representative sample of healthy children born at term in our centers and concurrently assessed by the same examiners as for our high-risk infants and 3 to help identify and address when drift occurs over time in conducting and scoring Bayley assessments
Evaluating development of motor skills cognitive skills language and behavior
Determining mortality and the prevalence of specific medical conditions
Assessing the relationship between growth and neurodevelopmental outcome
Assessing the relationship between the socioeconomic status and developmental outcome
Assessing the use of special support services and early intervention programs by this population
Evaluating the need for follow-up at school age
The scheduled evaluations collect demographic information socioeconomic status medical history medications medical equipment required growth data a detailed neurologic examination Bayley Scales of Infant Development mental motor infant behavior Child Behavior Checklist
A sub-study will assess a reference group comprised of a limited number of healthy term infants born in Network centers to meet the following three aims 1 to avoid potential ascertainment biases due to examiner expectations when only extremely preterm or other high-risk infants are assessed 2 in the absence of well-developed norms for the Bayley Scales to define thresholds for impairment based on data for a representative sample of healthy children born at term in our centers and concurrently assessed by the same examiners as for our high-risk infants and 3 to help identify and address when drift occurs over time in conducting and scoring Bayley assessments
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 |
|---|---|---|---|
| U01HD019897 | NIH | None | None |
| U01HD021466 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD021415 | NIH | None | None |
| U01HD021438 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027856 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD027881 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD034167 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| U10HD036790 | NIH | None | None |
| U10HD040461 | NIH | None | None |
| U10HD040492 | NIH | None | None |
| U10HD040498 | NIH | None | None |
| U10HD040521 | NIH | None | None |
| U10HD040689 | NIH | None | None |
| U10HD042638 | NIH | None | None |
| U10HD053089 | NIH | None | None |
| U10HD053109 | NIH | None | None |
| U10HD053119 | NIH | None | None |
| U10HD053124 | NIH | None | None |
| UL1RR024139 | NIH | None | None |
| UL1RR025744 | NIH | None | None |
| M01RR000633 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000997 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| M01RR001032 | NIH | None | None |
| M01RR002172 | NIH | None | None |
| M01RR002635 | NIH | None | None |
| M01RR007122 | NIH | None | None |
| M01RR016587 | NIH | None | None |
| UG1HD087226 | NIH | None | None |
| UG1HD112079 | NIH | None | None |
| UG1HD112097 | NIH | None | None |
| UG1HD112100 | NIH | None | httpsreporternihgovquickSearchUG1HD112100 |