Follow-up Visit of High Risk Infants
a study on Low Birth Weight Premature Birth
Summary
- Eligibility
- for people ages 18 months to 26 months (full criteria)
- Location
- at Los Angeles 5368361, California 5332921 and other locations
- Dates
- study startedstudy ends around
- Principal Investigator
- by Uday Devaskar, MD
Description
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.
Details
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 month corrected age). The goal of the study is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment, including:
- Evaluating development of motor skills, cognitive skills, language and behavior
- Determining mortality and the prevalence of specific medical conditions
- Assessing the relationship between growth and neurodevelopmental outcome
- Assessing the relationship between the socioeconomic status and developmental outcome
- Assessing the use of special support services and early intervention programs by this population
- Evaluating the need for follow-up at school age.
The scheduled evaluations collect: demographic information; socioeconomic status; medical history; medications; medical equipment required; growth data; a detailed neurologic examination; Bayley Scales of Infant Development (mental, motor, infant behavior); Child Behavior Checklist.
A sub-study will assess a reference group comprised of a limited number of healthy term infants born in Network centers to meet the following three aims: 1) to avoid potential ascertainment biases due to examiner expectations when only extremely preterm or other high-risk infants are assessed 2) in the absence of well-developed norms for the Bayley Scales, to define thresholds for impairment based on data for a representative sample of healthy children born at term in our centers and concurrently assessed by the same examiners as for our high-risk infants; and 3) to help identify and address when "drift" occurs over time in conducting and scoring Bayley assessments.
Keywords
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Neurodevelopmental Outcome, Follow up studies, Premature Birth
Eligibility
For people ages 18 months to 26 months
- 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.
Locations
- University of California - Los Angeles
accepting new patients
Los Angeles 5368361 California 5332921 90025 United States - Sharp Mary Birch Hospital for Women & Newborns
not yet accepting patients
San Diego 5391811 California 5332921 92123 United States - University of California at San Diego
completed
San Diego 5391811 California 5332921 92103-8774 United States - Stanford University
accepting new patients
Palo Alto 5380748 California 5332921 94304 United States
Lead Scientist at UCLA
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- NICHD Neonatal Research Network
- Links
- NICHD Neonatal Research Network
- ID
- NCT00009633
- Study Type
- Observational
- Participants
- Expecting 68000 study participants
- Last Updated