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| 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 (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 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 |
| 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) |
| Groups/Cohorts |
|---|
|
1
All infants included in the database.
|
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 |
| Sampling Method: | Probability Sample |
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.
Infants inborn at NICHD NRN centers that are:
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| 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 |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD 205-934-4680 wcarlo@peds.uab.edu | |
| Contact: Monica V. Collins, RN BSN (205) 934-5771 mcollins@peds.uab.edu | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD 650-723-5711 vanmeurs@leland.stanford.edu | |
| Contact: M. Bethany Ball, BS CCRC (650) 725-8342 mbball@stanford.edu | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| United States, Connecticut | |
| Yale University | Recruiting |
| New Haven, Connecticut, United States, 06504 | |
| Contact: Richard A. Ehrenkranz, MD 203-688-2895 richard.ehrenkranz@yale.edu | |
| Contact: Monica Konstantino, RN BSN (203) 688-7987 monica.konstantino@yale.edu | |
| Principal Investigator: Richard A. Ehrenkranz, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Barbara J. Stoll, MD 404-727-5740 barbara_stoll@oz.ped.emory.edu | |
| Contact: Ellen Hale, RN BS (404) 616-4218 ellen_hale@oz.ped.emory.edu | |
| Principal Investigator: Barbara J. Stoll, MD | |
| Sub-Investigator: Shannon Hamrick, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Brenda B. Poindexter, MD MS 317-274-3592 bpoindex@iupui.edu | |
| Contact: Leslie D. Wilson, RN BSN (317) 274-8255 ldw@iupui.edu | |
| Principal Investigator: Brenda B. Poindexter, MD MS | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Edward F. Bell, MD 319-356-4006 edward-bell@uiowa.edu | |
| Contact: Karen J. Johnson, RN BSN (319) 356-2924 karen-johnson@uiowa.edu | |
| Principal Investigator: Edward F. Bell, MD | |
| United States, Massachusetts | |
| Tufts Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Ivan D. Frantz III, MD 617-636-5322 ifrantz@tufts-nemc.org | |
| Contact: Brenda L. MacKinnon, RNC (617) 636-1218 bmackinnon@tufts-nemc.org | |
| Principal Investigator: Ivan D. Frantz III, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Seetha Shankaran, MD 313-745-1436 sshankar@med.wayne.edu | |
| Contact: Rebecca Bara, RN BSN (313) 745-1436 rbara@med.wayne.edu | |
| Principal Investigator: Seetha Shankaran, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kristi L. Watterberg, MD 505-272-3967 kwatterberg@salud.unm.edu | |
| Contact: Conra Backstrom Lacy, RN (505) 272-0367 cbackstrom@salud.unm.edu | |
| Principal Investigator: Kristi L. Watterberg, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Ronald N. Goldberg, MD 919-681-6025 goldb008@mc.duke.edu | |
| Contact: Katherine A. Foy (919) 668-3360 foy00004@mc.duke.edu | |
| Principal Investigator: Ronald N. Goldberg, MD | |
| RTI International | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Abhik Das, PhD 301-770-8214 adas@rti.org | |
| Contact: Kristin Zaterka-Baxter, RN (919) 485-7750 kzaterka@rti.org | |
| Principal Investigator: Abhik Das, PhD | |
| United States, Ohio | |
| Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele C. Walsh, MD MS 216-844-3759 mcw3@cwru.edu | |
| Contact: Nancy S. Newman, BA RN (216) 368-3084 nxs5@cwru.edu | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Kurt Schibler, MD 513-636-3972 kurt.schibler@cchmc.org | |
| Contact: Cathy Grisby, BSN CCRC (513) 558-4953 grisbyca@email.uc.edu | |
| Principal Investigator: Kurt Schibler, MD | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Abbot R. Laptook, MD 401-274-1122 alaptook@WIHRI.org | |
| Contact: Angelita Hensman (401) 274-1122 ahensman@wihri.org | |
| Principal Investigator: Abbot R. Laptook, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Pablo J. Sanchez, MD 214-648-3753 Pablo.Sanchez@UTSouthwestern.edu | |
| Contact: Nancy A. Miller, RN (214) 648-3780 Nancy.Miller@UTSouthwestern.edu | |
| Principal Investigator: Pablo J. Sanchez, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Roger G. Faix, MD 801-581-7052 roger.faix@hsc.utah.edu | |
| Contact: Karen A. Osborne, RN BSN (801) 213-3298 karen.osborne@hsc.utah.edu | |
| Principal Investigator: Roger G. Faix, MD | |
| 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 |
| 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
| Responsible Party: | Brown University, Women & Infants Hospital of Rhode Island ( Betty R. Vohr, Study Principal Investigator ) |
| Study ID Numbers: | NICHD-NRN-0006, U10 HD21364 (Case), U10 HD21373 (UT Houston), U10 HD21385 (Wayne State), U10 HD27851 (Emory), U10 HD27853 (Cincinnati), U10 HD27856 (Indiana), U10 HD27871 (Yale), U10 HD27880 (Stanford), U10 HD27904 (Brown), U10 HD34216 (Alabama), U10 HD36790 (RTI), U10 HD40492 (Duke), U10 HD40689 (UT Dallas), U10 HD53089 (New Mexico), U10 HD53109 (Iowa), U10 HD53119 (Tufts), U10 HD53124 (Utah), CCTS KL2 RR24149 (Houston), CCTS UL1 RR24128 (Duke), CCTS UL1 RR24139 (Yale), CCTS UL1 RR24148 (Houston), CCTS UL1 RR24979 (Iowa), CCTS UL1 RR24982 (Dallas), CCTS UL1 RR24989 (Case), CCTS UL1 RR25008 (Emory), GCRC M01 RR30 (Duke), GCRC M01 RR633 (Dallas), GCRC M01 RR64 (Utah), GCRC M01 RR70 (Stanford), GCRC M01 RR750 (Indiana), GCRC M01 RR80 (Case), GCRC M01 RR8084 (Cincinnati) |
| Study First Received: | February 1, 2001 |
| Last Updated: | December 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00009633 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Neurodevelopmental Outcome Follow up studies |
|
Body Weight Birth Weight Signs and Symptoms |
