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Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants Clinical research trials and Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants. Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants  Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants
Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants
For Condition: Infant, Newborn, Diseases
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: 18 Months/24 Months
Genders: Both
Protocol Entry Criteria: - < 1000 g at birth - Patient enrolled at a Neonatal Research Network center
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BettyVohr, Principal Investigator, Brown University
University of Texas *Recruiting*
Houston, Texas,
United States
Recruiting Georgia McDavid 713-500-5734
Brown University *Recruiting*
Providence, Rhode Island,
United States
Recruiting Cynthia Mejia 401-453-7630
University of Alabama *Recruiting*
Birmingham, Alabama,
United States
Recruiting Susan Johnson 205-934-4531
Yale University *Recruiting*
New Haven, Connecticut,
United States
Recruiting Elaine Sherwonit 203-785-2710
Stanford University *Recruiting*
Stanford, California,
United States
Recruiting Anne DeBattista 650-724-5513
University of Tennessee *Recruiting*
Memphis, Tennessee,
United States
Recruiting Tina Hudson 901-448-5950
Wayne State University *Recruiting*
Detroit, Michigan,
United States
Recruiting Debra Driscoll 313-745-1436
University of Miami *Recruiting*
Miami, Florida,
United States
Recruiting Wendy Griffin 305-243-5808
University of Texas *Recruiting*
Dallas, Texas,
United States
Recruiting Jackie Hickman 214-640-2585
Case Western Reserve University *Recruiting*
Cleveland, Ohio,
United States
Recruiting Bonnie Siner 216-368-3084
University of Cincinnati *Recruiting*
Cincinnati, Ohio,
United States
Recruiting Tari Gratton 513-558-4039
Emory University *Recruiting*
Atlanta, Georgia,
United States
Recruiting Ellen Hale 404-616-4218
University of New Mexico *Recruiting*
Albuquerque, New Mexico,
United States
Recruiting Ginny Laadt 505-272-5551
Additional Information:
Study ID Numbers: NICHD-1008; U10 HD21397,U10 HD27880,M01 RR00750,U10 HD27871,U10 HD21385,U10 HD27853,U10 HD27881,U01 HD36790,U10 HD27904,U10 HD34216,M01 RR00997,M01 RR00750,U10 HD27851,M01 RR06022,U10 HD21415,M01 RR01032,U10 HD21373,M01 RR08084,U10 HD27856,M01 RR00070
Study Start Date: January 1993
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009633
Other Infant, Newborn, Diseases Studies:
1. Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants
2. Study of Morphine in Postoperative Infants to Allow Normal Ventilation
3. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
4. Electrogastrography (EGC) in premature infants with feeding intolerance
5. Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
Related Studies:
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Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants
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