RecruitingNot Applicable

Follow-up Visit of High Risk Infants

United States68,000 participantsStarted 1993-04-01

Plain-language 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.

Who can participate

Age range18 Months – 26 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

What they're measuring

To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner

Timeframe: Longitudinal database currently funded through 3/31/2016

Trial details

NCT IDNCT00009633

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2030-03-31

Contact for this trial

Susan R Hintz, MD, MS Epi

srhintz@stanford.edu

View on ClinicalTrials.gov More Infant, Newborn trials