Follow-up Visit of High Risk Infants

Conditions

Infant, Low Birth Weight | Infant, Newborn | Infant, Premature | Infant, Small for Gestational Age

Trial Phase

Phase 4

Trial Purpose and Description

Trial Purpose

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.


Trial Description

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.


Participation Guidelines

Age:
18 Months - 26 Months
Gender:
Both

Eligibility Criteria


- 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.
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Dates:
January 1993
Last Updated:
October 28, 2014
Study HIC#:

Clinicaltrials.gov ID: NCT00009633