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| Descriptive Information Fields | |||||
| Brief Title † | Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants | ||||
| Official Title † | Neurodevelopmental Follow-Up of Extremely Low Birth Weight (ELBW) Infants | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Observational | ||||
| Study Design † | Natural History, Longitudinal, Defined Population, Prospective Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Infant, Newborn, Diseases | ||||
| Intervention † | |||||
| MEDLINE PMIDs | 15973322, 15930228, 15741374, 15741371, 15724036, 15713907, 15547163, 15520109, 15286223, 15060228, 14523165, 14520225, 14510324, 14510321 | ||||
| Links | Click here for more information on NICHD clinical trials.  Click here for more information on the NICHD Neonatal Research Network. |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | |||||
| Start Date † | January 1993 | ||||
| Completion Date | |||||
| Eligibility Criteria † |
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| Gender | Both | ||||
| Ages | 18 Months to 24 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00009633 | ||||
| Organization ID | NICHD-1008 | ||||
| Secondary IDs †† | 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 | ||||
| Study Sponsor † | National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | January 2006 | ||||
| First Received Date † | February 1, 2001 | ||||
| Last Updated Date | October 31, 2006 | ||||
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