Conditions:
Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature
What is the purpose of this trial?
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants (approximately 2 pounds) born in participating Network centers will receive neurodevelopmental, neurosensory and functional assessment at 18-22 months corrected age. Data regarding pregnancy and neonatal outcome are collected prospectively. The goal of the study is to identify maternal and neonatal risk and protective factors for neurodevelopmental outcome.
Dates: January 1993 -
Study Status: Recruiting
Who can participate?
Ages Eligible: 18 Months - 22 Months
Gender Eligible: Both
- Infants inborn at NRN centers
- 401-1,000 grams birth weight, and/or 22 0/7 to 28 6/7 weeks (<29 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 29 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.
Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)
Phase: Phase 4
First Received: February 1, 2001
Last Updated: May 12, 2010
Clinicaltrials.gov ID:
NCT00009633
Study HIC # 9407007682
Conditions:
Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature
What is the purpose of this trial?
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants (approximately 2 pounds) born in participating Network centers will receive neurodevelopmental, neurosensory and functional assessment at 18-22 months corrected age. Data regarding pregnancy and neonatal outcome are collected prospectively. The goal of the study is to identify maternal and neonatal risk and protective factors for neurodevelopmental outcome.
show additional information...
hide additional information...
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 18-22 months 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 in ELBW infants
- 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); Family Resource Scale; Stein Functional Status II Measure and the Stein Impact on the Family Scale.
Dates: January 1993 -
Study Status: Recruiting
Who can participate?
Ages Eligible: 18 Months - 22 Months
Gender Eligible: Both
- Infants inborn at NRN centers
- 401-1,000 grams birth weight, and/or 22 0/7 to 28 6/7 weeks (<29 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 29 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.
Additional Locations
Alabama
University of Alabama
Birmingham, Alabama
California
Stanford University
Stanford, California
Florida
University of Miami
Miami, Florida
Georgia
Emory University
Atlanta, Georgia
Michigan
Wayne State University
Detroit, Michigan
New Mexico
University of New Mexico
Albuquerque, New Mexico
Ohio
Case Western Reserve University
Cleveland, Ohio
University of Cincinnati
Cincinnati, Ohio
Rhode Island
Brown University
Providence, Rhode Island
Tennessee
University of Tennessee
Memphis, Tennessee
Texas
University of Texas
Dallas, Texas
University of Texas
Houston, Texas
Publications
Ambalavanan N, Tyson JE, Kennedy KA, Hansen NI, Vohr BR, Wright LL, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Vitamin A supplementation for extremely low birth weight infants: outcome at 18 to 22 months. Pediatrics. 2005 Mar;115(3):e249-54. Epub 2005 Feb 15.
Castro L, Yolton K, Haberman B, Roberto N, Hansen NI, Ambalavanan N, Vohr BR, Donovan EF. Bias in reported neurodevelopmental outcomes among extremely low birth weight survivors. Pediatrics. 2004 Aug;114(2):404-10.
Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. Review.
Hintz SR, Kendrick DE, Stoll BJ, Vohr BR, Fanaroff AA, Donovan EF, Poole WK, Blakely ML, Wright L, Higgins R; NICHD Neonatal Research Network. Neurodevelopmental and growth outcomes of extremely low birth weight infants after necrotizing enterocolitis. Pediatrics. 2005 Mar;115(3):696-703.
Hintz SR, Kendrick DE, Vohr BR, Poole WK, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Changes in neurodevelopmental outcomes at 18 to 22 months' corrected age among infants of less than 25 weeks' gestational age born in 1993-1999. Pediatrics. 2005 Jun;115(6):1645-51.
Hintz SR, Poole WK, Wright LL, Fanaroff AA, Kendrick DE, Laptook AR, Goldberg R, Duara S, Stoll BJ, Oh W; NICHD Neonatal Research Network. Changes in mortality and morbidities among infants born at less than 25 weeks during the post-surfactant era. Arch Dis Child Fetal Neonatal Ed. 2005 Mar;90(2):F128-33.
Laptook AR, O'Shea TM, Shankaran S, Bhaskar B; NICHD Neonatal Network. Adverse neurodevelopmental outcomes among extremely low birth weight infants with a normal head ultrasound: prevalence and antecedents. Pediatrics. 2005 Mar;115(3):673-80.
Oh W, Tyson JE, Fanaroff AA, Vohr BR, Perritt R, Stoll BJ, Ehrenkranz RA, Carlo WA, Shankaran S, Poole K, Wright LL; National Institute of Child Health and Human Development Neonatal Research Network. Association between peak serum bilirubin and neurodevelopmental outcomes in extremely low birth weight infants. Pediatrics. 2003 Oct;112(4):773-9.
Ohls RK, Ehrenkranz RA, Das A, Dusick AM, Yolton K, Romano E, Delaney-Black V, Papile LA, Simon NP, Steichen JJ, Lee KG; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome and growth at 18 to 22 months' corrected age in extremely low birth weight infants treated with early erythropoietin and iron. Pediatrics. 2004 Nov;114(5):1287-91.
Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65.
Vohr BR, O'Shea M, Wright LL. Longitudinal multicenter follow-up of high-risk infants: why, who, when, and what to assess. Semin Perinatol. 2003 Aug;27(4):333-42. Review.
Vohr BR, Wright LL, Dusick AM, Perritt R, Poole WK, Tyson JE, Steichen JJ, Bauer CR, Wilson-Costello DE, Mayes LC; Neonatal Research Network. Center differences and outcomes of extremely low birth weight infants. Pediatrics. 2004 Apr;113(4):781-9.
Wadhawan R, Vohr BR, Fanaroff AA, Perritt RL, Duara S, Stoll BJ, Goldberg R, Laptook A, Poole K, Wright LL, Oh W. Does labor influence neonatal and neurodevelopmental outcomes of extremely-low-birth-weight infants who are born by cesarean delivery? Am J Obstet Gynecol. 2003 Aug;189(2):501-6.
Walsh MC, Morris BH, Wrage LA, Vohr BR, Poole WK, Tyson JE, Wright LL, Ehrenkranz RA, Stoll BJ, Fanaroff AA; National Institutes of Child Health and Human Development Neonatal Research Network. Extremely low birthweight neonates with protracted ventilation: mortality and 18-month neurodevelopmental outcomes. J Pediatr. 2005 Jun;146(6):798-804.
Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)
Phase: Phase 4
First Received: February 1, 2001
Last Updated: May 12, 2010
Clinicaltrials.gov ID:
NCT00009633
Study HIC # 9407007682
