Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age
Conditions
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Neurodevelopmental Outcome, Follow up studies
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.
Detailed 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 * 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.
Interventions
OTHERNo Intervention
No Intervention
Sponsors
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to 26 Months
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner | Longitudinal database currently funded through 3/31/2016 |
Secondary
| Measure | Time frame |
|---|---|
| To examine the relationship between baseline characteristics and outcome | Longitudinal database currently funded through 3/31/2016 |
| To provide data for hypothesis formulation and sample size calculation for Network multi-center studies | Longitudinal database currently funded through 3/31/2016 |
Countries
United States
Contacts
CONTACTSusan R Hintz, MD, MS Epi
CONTACTAbhik Das, PhD
PRINCIPAL_INVESTIGATORAbbot R. Laptook, MD
Brown University, Women & Infants Hospital of Rhode Island
PRINCIPAL_INVESTIGATORMichele C. Walsh, MD MS
Case Western Reserve University, Rainbow Babies and Children's Hospital
PRINCIPAL_INVESTIGATORC. Michael Cotten, MD, MHS
Duke University
PRINCIPAL_INVESTIGATORDavid P. Carlton, MD
Emory University
PRINCIPAL_INVESTIGATORGreg M. Sokol, MD
Indiana University
PRINCIPAL_INVESTIGATORAbhik Das, PhD
RTI International
PRINCIPAL_INVESTIGATORKrisa P. Van Meurs, MD
Stanford University
PRINCIPAL_INVESTIGATORBrenda B. Poindexter, MD
Children's Hospital Medical Center, Cincinnati
PRINCIPAL_INVESTIGATORWaldemar A. Carlo, MD
University of Alabama at Birmingham
PRINCIPAL_INVESTIGATOREdward F. Bell, MD
University of Iowa
PRINCIPAL_INVESTIGATORKristi L. Watterberg, MD
University of New Mexico
PRINCIPAL_INVESTIGATORMyra H. Wyckoff, MD
University of Texas, Southwestern Medical Center at Dallas
PRINCIPAL_INVESTIGATORJon E Tyson, MD, MPH
The University of Texas Health Science Center, Houston
PRINCIPAL_INVESTIGATORBradley A. Yoder, MD
University of Utah
PRINCIPAL_INVESTIGATORSeetha Shankaran, MD
Wayne State University
PRINCIPAL_INVESTIGATORWilliam E. Truog, MD
Children's Mercy Hospital Kansas City
PRINCIPAL_INVESTIGATORPablo J. Sanchez, MD
Research Institute at Nationwide Children's Hospital
PRINCIPAL_INVESTIGATORUday Devaskar, MD
University of California, Los Angeles
PRINCIPAL_INVESTIGATORCarl T D'Angio, MD
University of Rochester
PRINCIPAL_INVESTIGATOREric C Eichenwald, MD
University of Pennsylvania
Outcome results
None listed