18 Month Follow-up Visit of High Risk Infants - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00009633

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 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.

Condition	Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	18 Month Follow-up Visit of High Risk Infants

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	68000
Study Start Date:	January 1993
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	18 Months to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Infants inborn at NICHD NRN centers that are 401-1000 grams birth weight, and/or <29 weeks gestational age, OR infants enrolled in one or more additional NICHD NRN studies.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009633

Contacts

Contact: Betty R. Vohr, MD	(401) 274-1122 ext 1235	bvohr@wihri.org
Contact: Rosemary D. Higgins, MD	301-496-5575	higginsr@mail.nih.gov

Show 24 Study Locations

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

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

More Information

Additional Information:

Click here for more information on the NICHD Neonatal Research Network. This link exits the ClinicalTrials.gov site

Publications:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Brown University, Women & Infants Hospital of Rhode Island ( Betty R. Vohr, Study Principal Investigator )
Study ID Numbers:	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)
Study First Received:	February 1, 2001
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00009633 History of Changes
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Neurodevelopmental Outcome
Follow up studies

Study placed in the following topic categories:

Body Weight
Birth Weight
Signs and Symptoms

Additional relevant MeSH terms:

Body Weight
Birth Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 02, 2009