Generic Database of Very Low Birth Weight Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 14
SponsorNICHD Neonatal Research Network
About this trial
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 (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
401-1000 grams birth weight, and/or
20 0/7 to 28 6/7 weeks (<29 weeks) gestational age
Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and
Disqualifiers
Infants >1,000 grams birth weight and/or >29 weeks gestational age
Trial population
Infants inborn at NICHD NRN centers that are 401-1000 grams birth weight, and/or \<29 weeks gestational age, OR infants enrolled in one or more additional NICHD NRN studies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other intervention
Treatment groups
80,000 Participants
are divided into 1 treatment groupGroup A: Registry Cohort1 intervention
Trial outcomes
Primary outcomes
1
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
To maintain a registry of baseline and outcome data for VLBW infants with data collected
Time frame
Longitudinal database currently funded through 3/31/2030Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NICHD Neonatal Research Network
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov