| NCT ID | NCT00009633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NICHD Neonatal Research Network |
| Condition | Infant, Newborn |
| Study Type | OBSERVATIONAL |
| Enrollment | 68,000 participants |
| Start Date | 1993-04-01 |
| Primary Completion | 2030-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 68,000 participants in total. It began in 1993-04-01 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 NICHD Neonatal Research Network's 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.
Eligibility Criteria
* Infants inborn at NRN centers * \<27 weeks gestational age * Infants enrolled in one or more additional NICHD NRN Follow-up studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria 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 27 weeks may be included in the FU Study. Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, infants with birth weights between 401 and 1500 grams who were admitted to NRN NICUs within 14 days of birth were included in the database.
Contact & Investigator
Susan R Hintz, MD, MS Epi
✉ srhintz@stanford.eduAbbot R. Laptook, MD
PRINCIPAL INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Frequently Asked Questions
Who can join the NCT00009633 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 26 Months, 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 NCT00009633 currently recruiting?
Yes, NCT00009633 is actively recruiting participants. Contact the research team at srhintz@stanford.edu for enrollment information.
Where is the NCT00009633 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 NCT00009633 clinical trial?
NCT00009633 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 68,000 participants.