| February 1, 2001 |
| April 1, 2009 |
| January 1993 |
| March 2011 (final data collection date for primary outcome measure) |
| To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00009633 on ClinicalTrials.gov Archive Site |
- To examine the relationship between baseline characteristics and outcome [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
- To provide data for hypothesis formulation and sample size calculation for Network multi-center studies [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| 18 Month Follow-up Visit of High Risk Infants |
| 18 Month Follow-up Visit of High Risk Infants |
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 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 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. |
| Phase IV |
| Observational |
| Cohort, Prospective |
- Infant, Newborn
- Infant, Low Birth Weight
- Infant, Small for Gestational Age
- Infant, Premature
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| |
| |
- 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.
- 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, 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Tyson JE, Parikh NA, Langer J, Green C, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Intensive care for extreme prematurity--moving beyond gestational age. N Engl J Med. 2008 Apr 17;358(16):1672-81.
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| |
| Recruiting |
| 68000 |
| March 2011 |
| March 2011 (final data collection date for primary outcome measure) |
- 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. |
| Both |
| 18 Months to 24 Months |
| No |
|
|
| United States |
| |
| NCT00009633 |
| Betty R. Vohr, Study Principal Investigator, Brown University, Women & Infants Hospital of Rhode Island |
| NICHD-NRN-0006, U01 HD19897 (GWU), U01 HD21466 (Vermont), U10 HD21364 (Case), U10 HD21373 (UT Houston), U10 HD21385 (Wayne), U10 HD21397 (Miami), U10 HD21415 (Tenn), U10 HD21438 (Alabama), U10 HD27851 (Emory), U10 HD27853 (Cincinnati), U10 HD27856 (Indiana), U10 HD27871 (Yale), U10 HD27880 (Stanford), U10 HD27881 (UNM), U10 HD27904 (Brown), U10 HD34167 (Harvard), U10 HD34216 (Alabama), U10 HD36790 (RTI), U10 HD40461 (UCSD), U10 HD40492 (Duke), U10 HD40498 (Wake), U10 HD40521 (Rochester), U10 HD40689 (UT Southwestern), U10 HD42638 (Tennessee), U10 HD53089 (UNM), U10 HD53109 (Iowa), U10 HD53119 (Tufts), U10 HD53124 (Utah), CTSA UL1 RR24139 (Yale), CTSA UL1 RR25744 (Stanford), CTSA UL1 RR25764 (Utah), CTSA UL1 RR25777 (Alabama), GCRC M01 RR30 (Duke), GCRC M01 RR32 (Alabama), GCRC M01 RR39 (Emory), GCRC M01 RR44 (Rochester), GCRC M01 RR54 (Tufts), GCRC M01 RR59 (Iowa), GCRC M01 RR64 (Utah), GCRC M01 RR70 (Stanford), GCRC M01 RR80 (Case), GCRC M01 RR633 (UT Southwest.), GCRC M01 RR750 (Indiana), GCRC M01 RR997 (UNM), GCRC M01 RR8084 (Cincinnati), GCRC M01 RR1032 (Harvard), GCRC M01 RR2172 (Harvard), GCRC M01 RR2588 (UT Houston), GCRC M01 RR2635 (Harvard), GCRC M01 RR6022 (Yale), GCRC M01 RR7122 (Wake), GCRC M01 RR16587 (Miami) |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|
| Principal Investigator: |
Abbot R. Laptook, MD |
Brown University, Women & Infants Hospital of Rhode Island |
|
| Principal Investigator: |
Michele C. Walsh, MD MS |
Case Western Reserve University, Rainbow Babies and Children's Hospital |
|
| Principal Investigator: |
Ronald N. Goldberg, MD |
Duke University |
|
| Principal Investigator: |
Barbara J. Stoll, MD |
Emory University |
|
| Principal Investigator: |
Brenda B. Poindexter, MD MS |
Indiana University |
|
| Principal Investigator: |
Abhik Das, PhD |
RTI International |
|
| Principal Investigator: |
Krisa P. Van Meurs, MD |
Stanford University |
|
| Principal Investigator: |
Ivan D. Frantz III, MD |
Tufts Medical Center |
|
| Principal Investigator: |
Kurt Schibler, MD |
University of Cincinnati |
|
| Principal Investigator: |
Waldemar A. Carlo, MD |
University of Alabama at Birmingham |
|
| Principal Investigator: |
Edward F. Bell, MD |
University of Iowa |
|
| Principal Investigator: |
Kristi L. Watterberg, MD |
University of New Mexico |
|
| Principal Investigator: |
Pablo J. Sanchez, MD |
University of Texas Southwestern Medical Center at Dallas |
|
| Principal Investigator: |
Kathleen A. Kennedy, MD MPH |
The University of Texas Health Science Center, Houston |
|
| Principal Investigator: |
Roger G. Faix, MD |
University of Utah |
|
| Principal Investigator: |
Seetha Shankaran, MD |
Wayne State University |
|
| Principal Investigator: |
Richard A. Ehrenkranz, MD |
Yale University |
|
|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| March 2009 |