Follow-up Visit of High Risk Infants



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:January 1993
End Date:March 2021
Contact:Susan R Hintz, MD, MS Epi
Email:srhintz@stanford.edu

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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.

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

- Identifying significant family stress in this population and compliance with medical and
developmental care

- 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.

- Infants inborn at NRN centers

- 401-1,000 grams birth weight, and/or 22 0/7 to 26 6/7 weeks (<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.
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