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Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants

This study is currently recruiting participants.
Verified by National Institute of Child Health and Human Development (NICHD), January 2006

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: 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 (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.


Condition Phase
Infant, Newborn, Diseases
Phase IV

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:   Neurodevelopmental Follow-Up of Extremely Low Birth Weight (ELBW) Infants

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

Study Start Date:   January 1993

Detailed Description:

A multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental, neurosensory and functional assessment at 18-22 months corrected age. Data regarding pregnancy and neonatal outcome are collected prospectively. Social and economic status information (SES) and a detailed interim medical history are obtained at the time of the assessment. The scheduled evaluations at 18 - 22 months corrected age include: 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.

The goal of the study is to identify maternal and neonatal risk and protective factors for neurodevelopmental outcome. Additional objectives of the study include: to characterize development in the areas of motor skills, cognitive skills, language and behavior; to determine the mortality and the prevalence of specific medical morbidities in ELBW infants; to characterize the relationship between growth and neurodevelopmental outcome; to assess the relationship between the socioeconomic status and developmental outcome; to identify significant family stress in this population and compliance with medical and developmental care; to assess the utilization of special support services and early intervention programs by this population; and finally, to evaluate the need for follow-up to school age. The Follow-Up Study has maintained its goal of greater than or equal to 80 percent follow-up compliance rate.

  Eligibility
Ages Eligible for Study:   18 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • < 1000 g at birth
  • Patient enrolled at a Neonatal Research Network center
  Contacts and Locations

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

Contacts
Contact: Rosemary Higgins     301-496-5575     higginsr@mail.nih.gov    

Locations
United States, Alabama
University of Alabama     Recruiting
      Birmingham, Alabama, United States
      Contact: Susan Johnson, RN     205-934-4531        
      Principal Investigator: Kathleen Nelson, MD            
United States, California
Stanford University     Recruiting
      Stanford, California, United States
      Contact: Anne DeBattista, RN     650-724-5513        
      Principal Investigator: Toby Cohen, MD            
United States, Connecticut
Yale University     Recruiting
      New Haven, Connecticut, United States
      Contact: Elaine Sherwonit     203-785-2710        
      Principal Investigator: Linda Mayes, MD            
United States, Florida
University of Miami     Recruiting
      Miami, Florida, United States
      Contact: Wendy Griffin, RN     305-243-5808        
      Principal Investigator: Charles Bauer, MD            
United States, Georgia
Emory University     Recruiting
      Atlanta, Georgia, United States
      Contact: Ellen Hale, RN     404-616-4218        
      Principal Investigator: Neal Simon, MD            
United States, Michigan
Wayne State University     Recruiting
      Detroit, Michigan, United States
      Contact: Debra Driscoll     313-745-1436        
      Principal Investigator: Virginia Delaney-Black, MD            
United States, New Mexico
University of New Mexico     Recruiting
      Albuquerque, New Mexico, United States
      Contact: Ginny Laadt, PhD     505-272-5551        
United States, Ohio
Case Western Reserve University     Recruiting
      Cleveland, Ohio, United States
      Contact: Bonnie Siner, RN     216-368-3084        
      Principal Investigator: Dee Wilson, MD            
University of Cincinnati     Recruiting
      Cincinnati, Ohio, United States
      Contact: Tari Gratton, RN     513-558-4039        
      Principal Investigator: Jean Steichen, MD            
United States, Rhode Island
Brown University     Recruiting
      Providence, Rhode Island, United States
      Contact: Cynthia Mejia, RN     401-453-7630        
      Principal Investigator: Betty Vohr, MD            
United States, Tennessee
University of Tennessee     Recruiting
      Memphis, Tennessee, United States
      Contact: Tina Hudson, RN     901-448-5950        
      Principal Investigator: Henrietta Bada, MD            
United States, Texas
University of Texas     Recruiting
      Dallas, Texas, United States
      Contact: Jackie Hickman, RN     214-640-2585        
      Principal Investigator: Sue Broyles, MD            
University of Texas     Recruiting
      Houston, Texas, United States
      Contact: Georgia McDavid     713-500-5734        
      Principal Investigator: Brenda Morris, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Betty Vohr, MD     Brown University    
  More Information

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

Publications of Results:
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.
 

Publications indexed to this study:

Study ID Numbers:   NICHD-1008, U10 HD34216, U10 HD27856, U10 HD21397, U10 HD27853, U10 HD27871, U10 HD21415, U10 HD27904, U10 HD27881, U10 HD21385, U10 HD27851, U10 HD27880, U10 HD21373, U01 HD36790, M01 RR08084, M01 RR00750, M01 RR06022, M01 RR00750, M01 RR00997, M01 RR00070, M01 RR01032
First Received:   February 1, 2001
Last Updated:   October 31, 2006
ClinicalTrials.gov Identifier:   NCT00009633
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Child Health and Human Development (NICHD):
Neurodevelopment  
Infant, premature  
Infant, extremely-low-birth-weight  
Infant, Very Low Birth Weight
Infant, low birth weight
Follow up studies

Study placed in the following topic categories:
Body Weight
Birth Weight
Signs and Symptoms
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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