NCT00063063 Generic Database of Very Low Birth Weight Infants
| NCT ID | NCT00063063 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NICHD Neonatal Research Network |
| Condition | Infant, Newborn |
| Study Type | OBSERVATIONAL |
| Enrollment | 80,000 participants |
| Start Date | 1987-04-01 |
| Primary Completion | 2030-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80,000 participants in total. It began in 1987-04-01 with a primary completion date of 2030-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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
Inclusion Criteria: * Infants inborn at NICHD NRN centers that are: * 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 exclusion criteria for the Generic Database are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 29 weeks may be included in the GDB. Exclusion Criteria: * Infants \>1,000 grams birth weight and/or \>29 weeks gestational age Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, all infants with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days of birth were included in the database.
Contact & Investigator
Abbot R Laptook, MD
PRINCIPAL INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Frequently Asked Questions
Who can join the NCT00063063 clinical trial?
This trial is open to participants of all sexes, up to 14 Days, studying Infant, Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00063063 currently recruiting?
Yes, NCT00063063 is actively recruiting participants. Contact the research team at rmpatel@emory.edu for enrollment information.
Where is the NCT00063063 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Palo Alto, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT00063063 clinical trial?
NCT00063063 is sponsored by NICHD Neonatal Research Network. The principal investigator is Abbot R Laptook, MD at Brown University, Women & Infants Hospital of Rhode Island. The trial plans to enroll 80,000 participants.