Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063063
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2003-06-19
Brief Title:
Generic Database of Very Low Birth Weight Infants
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Generic Database A Survey of Morbidity and Mortality in Very Low Birth Weight 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:
GDB
Brief Summary:
The Generic Database GDB is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network NRN centers The GDB collects observational baseline data on both mothers and infants and the therapies used and outcomes of the infants The information collected is not specific to a disease or treatment ie it is generic Data are analyzed to find associations and trends between baseline information treatments and infant outcome and to develop future NRN trials
Detailed Description:
The Generic Database GDB is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network NRN centers The purpose is to collect baseline and outcome data in a uniform manner on a large cohort of VLBW and other sick infants admitted to neonatal intensive care units
The GDB collects observational baseline data on both mothers and infants and the therapies used and outcomes of the infants The information collected is not specific to a disease or treatment ie it is generic Baseline data is collected soon after admission to the NICU outcome data is collected at the time of death or discharge from the hospital The data collected includes information on
Demographics of mother and infant
Mothers health eg pregnancy history and complications
Labor and deliver eg rupture of the membranes steroids and antibiotics given mode of delivery
Infants health gestational age Apgar scores weight length delivery room resuscitation respiratory support etc
Infants medical outcome heart lung nervous system gastrointestinal system hearing and vision known infections and major malformationssyndromes and mortality or number of days hospitalized
These data are used to examine associations between baseline characteristics treatments and outcomes to track trends in incidences of disease and effectiveness of therapies and to identify questions requiring additional in-depth research
Informed Consent As required by local IRBs
Secondary Studies include
A The All Birth Cohort ABC Study A time-limited observational registry to determine the incidence of intrapartum stillbirth at 20 07 - 28 67 weeks gestation and its associated factors at Network sites
The GDB collects observational baseline data on both mothers and infants and the therapies used and outcomes of the infants The information collected is not specific to a disease or treatment ie it is generic Baseline data is collected soon after admission to the NICU outcome data is collected at the time of death or discharge from the hospital The data collected includes information on
Demographics of mother and infant
Mothers health eg pregnancy history and complications
Labor and deliver eg rupture of the membranes steroids and antibiotics given mode of delivery
Infants health gestational age Apgar scores weight length delivery room resuscitation respiratory support etc
Infants medical outcome heart lung nervous system gastrointestinal system hearing and vision known infections and major malformationssyndromes and mortality or number of days hospitalized
These data are used to examine associations between baseline characteristics treatments and outcomes to track trends in incidences of disease and effectiveness of therapies and to identify questions requiring additional in-depth research
Informed Consent As required by local IRBs
Secondary Studies include
A The All Birth Cohort ABC Study A time-limited observational registry to determine the incidence of intrapartum stillbirth at 20 07 - 28 67 weeks gestation and its associated factors at Network sites
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 |
|---|---|---|---|
| UG1HD112100 | NIH | None | httpsreporternihgovquickSearchUG1HD112100 |
| 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 |
| M01RR000032 | NIH | None | None |
| M01RR000039 | NIH | None | None |
| M01RR000044 | NIH | None | None |
| M01RR000054 | NIH | None | None |
| M01RR000059 | NIH | None | None |
| M01RR000064 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| M01RR000080 | 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 |
| U10HD068244 | NIH | None | None |
| U10HD068263 | NIH | None | None |
| U10HD068270 | NIH | None | None |
| U10HD068278 | NIH | None | None |
| U10HD068284 | NIH | None | None |
| UG1HD034216 | NIH | None | None |
| UG1HD027904 | NIH | None | None |
| UG1HD021364 | NIH | None | None |
| UG1HD027853 | NIH | None | None |
| UG1HD040689 | NIH | None | None |
| UG1HD040492 | NIH | None | None |
| UG1HD027851 | NIH | None | None |
| UG1HD087229 | NIH | None | None |
| UG1HD027856 | NIH | None | None |
| UG1HD053109 | NIH | None | None |
| UG1HD068284 | NIH | None | None |
| UG1HD068278 | NIH | None | None |
| UG1HD068244 | NIH | None | None |
| UG1HD068263 | NIH | None | None |
| UG1HD027880 | NIH | None | None |
| UG1HD068270 | NIH | None | None |
| UG1HD053089 | NIH | None | None |
| UG1HD087226 | NIH | None | None |
| UG1HD112079 | NIH | None | None |
| UG1HD112097 | NIH | None | None |