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| 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 |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Neurodevelopmental Follow-Up of Extremely Low Birth Weight (ELBW) Infants |
| Study Start Date: | January 1993 |
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 |
Contacts and Locations| Contact: Rosemary Higgins | 301-496-5575 | higginsr@mail.nih.gov |
| 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 | |||||
| Principal Investigator: | Betty Vohr, MD | Brown University |
More Information
Click here for more information on NICHD clinical trials. 
  |
Click here for more information on the NICHD Neonatal Research Network. 
  |
| 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 |
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