Generic Database of Very Low Birth Weight Infants

Официальное название

Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants

Обзор

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Подробное описание

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a large cohort of VLBW and other sick infants admitted to neonatal intensive care units.

The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital. The data collected includes information on:

* Demographics of mother and infant * Mother's health (e.g., pregnancy history and complications) * Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery) * Infant's health (gestational age, Apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.) * Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized).

These data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research.

Informed Consent: As required by local IRBs.

Secondary Studies include:

A. The All Birth Cohort (ABC) Study. A time-limited observational registry to determine the incidence of intrapartum stillbirth at 20 0/7 - 28 6/7 weeks' gestation and its associated factors at Network sites.

Вмешательства

• Другое No Intervention

Первичные конечные точки

• To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [Срок оценки: Longitudinal database currently funded through 3/31/2030]

Критерии участия

Критерии включения

• Infants inborn at NICHD NRN centers that are:
• 401-1000 grams birth weight, and/or
• 20 0/7 to 28 6/7 weeks (<29 weeks) gestational age
• Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria for the Generic Database are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 29 weeks may be included in the GDB.

Критерии исключения

• Infants >1,000 grams birth weight and/or >29 weeks gestational age

Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, all infants with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days of birth were included in the database.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 31 центр

• University of Alabama at Birmingham — Birmingham
• University of California - Los Angeles — Los Angeles
• Stanford University — Palo Alto
• University of California at San Diego — San Diego
• Sharp Mary Birch Hospital for Women & Newborns — San Diego
• Yale University — New Haven
• George Washington University — Washington D.C.
• University of Miami — Miami
• … и ещё 23 центра

Публикации

• Strand M, Jobe AH. The multiple negative randomized controlled trials in perinatology--why? Semin Perinatol. 2003 Aug;27(4):343-50. doi: 10.1016/s0146-0005(03)00042-9. PMID 14510325
• Tyson JE, Stoll BJ. Evidence-based ethics and the care and outcome of extremely premature infants. Clin Perinatol. 2003 Jun;30(2):363-87. doi: 10.1016/s0095-5108(03)00028-9. PMID 12875360
• Wright LL. How to develop and manage a successful research network. Semin Pediatr Surg. 2002 Aug;11(3):175-80; discussion 180. doi: 10.1053/spsu.2002.33740. No abstract available. PMID 12145760
• Wright LL, McNellis D. National Institute of Child Health and Human Development (NICHD)-sponsored Perinatal Research Networks. Semin Perinatol. 1995 Apr;19(2):112-23. doi: 10.1016/s0146-0005(05)80031-x. No abstract available. PMID 7604302
• Adams-Chapman I, Hansen NI, Stoll BJ, Higgins R; NICHD Research Network. Neurodevelopmental outcome of extremely low birth weight infants with posthemorrhagic hydrocephalus requiring shunt insertion. Pediatrics. 2008 May;121(5):e1167-77. doi: 10.1542/peds.2007-0423. Epub 2008 Apr 7. PMID 18390958
• Ambalavanan N, Carlo WA, Bobashev G, Mathias E, Liu B, Poole K, Fanaroff AA, Stoll BJ, Ehrenkranz R, Wright LL; National Institute of Child Health and Human Development Neonatal Research Network. Prediction of death for extremely low birth weight neonates. Pediatrics. 2005 Dec;116(6):1367-73. doi: 10.1542/peds.2004-2099. PMID 16322160
• Benjamin DK Jr, Stoll BJ, Fanaroff AA, McDonald SA, Oh W, Higgins RD, Duara S, Poole K, Laptook A, Goldberg R; National Institute of Child Health and Human Development Neonatal Research Network. Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months. Pediatrics. 2006 Jan;117(1):84-92. doi: 10.1542/peds.2004-2 PMID 16396864
• Broitman E, Ambalavanan N, Higgins RD, Vohr BR, Das A, Bhaskar B, Murray K, Hintz SR, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Clinical data predict neurodevelopmental outcome better than head ultrasound in extremely low birth weight infants. J Pediatr. 2007 Nov;151(5):500-5, 505.e1-2. doi: 10.1016/j.jpeds.2007.04.013. Epub 2007 Jul 12. PMID 17961693

Идентификаторы

NCT: NCT00063063 · NICHD-NRN-0001 · U24HD095254 · UG1HD068263 · UG1HD034216 · UG1HD021364 · UG1HD027853 · UG1HD027851 · UG1HD053109 · UG1HD112079 · UG1HD112093 · UG1HD027904 · UG1HD053089 · UG1HD068244 · UG1HD027880 · UG1HD087226 · UG1HD040689 · UG1HD040492 · UG1HD112097 · UG1HD112100 · UG1HD068278

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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