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Набор по приглашению NCT06823115

Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0

Наблюдательное Acute Kidney Injury Fluid Overload Prematurity Complications Risk Factors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury, Fluid Overload, Prematurity Complications, Risk Factors. Базовые параметры: 0 Minutes — 2 Weeks · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Австралия, Бразилия, Канада, Колумбия +14
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0: Towards Expanding Our Understanding of Neonatal Acute Kidney Injury

Обзор

There is a growing focus on short- and long-term kidney health in neonates, including those with acute kidney injury (AKI). AKI occurs commonly in the Neonatal Intensive Care Unit (NICU) and is associated with adverse outcomes. In addition to poor outcomes during the hospitalization, infants discharged from the NICU may have an increased burden of kidney disease during childhood. Studies of long-term kidney function in children born prematurely show a fourfold increase in chronic kidney disease (CKD) by adolescence and into adulthood. Despite the landmark findings of the Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) study, the limitations of this study are notable. First, the AWAKEN study enrolled infants admitted in 2014, making the data now over 10 years old. Much has changed in neonatal practice (e.g. increased AKI awareness, treatment strategies). Secondly, the findings of the AWAKEN study were geographically limited. While the AWAKEN study was multi-national and multi-center, it represented only 24 centers (22 from North America, 1 from India and 1 from Australia). Finally, information collected from AWAKEN ended at hospital discharge. The investigators seek to leverage the strength of the Neonatal Kidney Collaborative along with other organizations and collaboratives interested in neonatal kidney health to address these gaps. Therefore, the investigators are conducting a second, modified iteration of this study entitled "AWAKEN 2.0". AWAKEN 2.0 will be a multi-center multi-national retrospective analysis utilizing similar methodology to the AWAKEN study.

Подробное описание

AWAKEN 2.0 is a multi-center multi-national retrospective analysis utilizing similar methodology to the AWAKEN study. The investigators will capture information on all infants admitted to participating level 3 and 4 NICUs between January 1-March 31, 2019, to answer specific hypothesis regarding the following three inter-connected but independent specific aims:

Specific Aim 1. Describe prevalence of AKI in a multi-national multi-center retrospective cohort, 5 years after the original AWAKEN study.

1. Primary hypothesis: The investigators hypothesize that rates of neonatal AKI are higher than the rate described in the original AWAKEN study. 2. Population:

1. Inclusion Criteria include all infants admitted to participating NICUs between 1/1/19- 3/31/19 and receiving \> 48 hours of IV fluids 2. Exclusion Criteria include age \> 14 days at admission, congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days, lethal chromosomal anomalies and/or neonatal mortality \<48 hours 3. Primary Outcome - Neonatal AKI 4. Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies, site characteristics.

Specific Aim 2. Determine if AKI is independently associated with mortality, length of stay, and discharge serum creatinine (SCr).

1. The investigators hypothesize that higher stages of AKI are associated with higher mortality, longer lengths of stay and higher serum creatinine at discharge, even after controlling for confounding factors. 2. Populations - Same as Specific Aim 1. 3. Primary Exposure - Neonatal AKI definitions (table 3) 4. Primary Outcome - Survival 5. Secondary outcomes will include: Hospital length of stay, BPD. 6. Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies, 7. Exploratory outcomes - recognize that the proposed definition may not be the best definition to predict clinical outcomes. Also recognize that there may be a need to have different definitions for premature infants. The investigators plan to explore how other definitions reported in the literature can predict these outcomes (for example using the 90th % for normative values). In addition, this will have the largest comprehensive database to explore new definitions which could incorporate fluid balance and other factors.

Specific Aim 3. Determine if AKI can predict chronic kidney disease, recurrent AKI and hypertension during early childhood.

1. The investigators hypothesize that higher stages of AKI are associated with chronic kidney disease and recurrent AKI during early childhood. 2. Population - Same as Specific Aim 1 3. Primary Exposure - Neonatal AKI definitions (table 3) 4. Primary Outcome - Childhood CKD 5. Secondary Outcomes - Childhood hypertension, recurrent AKI and childhood ESRD.

Each participating site will screen all neonates admitted to the NICU during the 3 months of study and capture additional data on those who meet the same inclusion and exclusion criteria as the original cohort. There will be 6 different integrated forms.

1. Screening form (all infants) 2. Baseline form for included infants (maternal demographic data, admission indication) 3. First 14 days form (i.e. urine output, medications and respiratory support) 4. Serum creatinine data (all values from date of birth to date of IRB approval) 5. Discharge form (discharge diagnoses, medications, follow-up anticipated) 6. Follow-up Information (clinically obtained follow-up after discharge)

Первичные конечные точки

  • Neonatal Acute Kidney Injury [Срок оценки: Up to 6 months or NICU discharge, whichever comes first]
Вторичные конечные точки (6)
  • Risk factors for Neonatal AKI [Срок оценки: Up to 6 months or NICU discharge, whichever comes first]
  • Fluid Overload [Срок оценки: NICU admission through discharge.]
  • Mortality [Срок оценки: Up to 6 months or NICU discharge, whichever comes first]
  • Chronic Kidney Disease [Срок оценки: NICU discharge to 5 year follow-up]
  • Hypertension [Срок оценки: NICU discharge to 5 year follow-up]
  • Proteinuria [Срок оценки: NICU discharge to 5 year follow-up]

Критерии участия

Критерии включения

  • All infants born or admitted to a participating level 3 or 4 NICU between 1/1/19- 3/31/19 will be screened.
  • Infants who received intravenous fluids for > 48 hours will be eligible.

Критерии исключения

  • Age > 14 days at admission
  • Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days
  • Lethal chromosomal anomalies
  • Neonatal mortality <48 hours

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 · 50 центров
  • University of Alabama at Birmingham — Birmingham
  • University of Arkansas for Medical Sciences — Little Rock
  • Stanford Children's — Palo Alto
  • Rady Children's Hospital/UCSD — San Diego
  • Children's Hospital Colorado — Aurora
  • Yale University — New Haven
  • Children's National Hospital — Washington D.C.
  • Miami Children's / Nichlaus Children's Hospital — Miami
  • … и ещё 42 центра
Канада · 7 центров
  • The Hospital for Sick Children — Toronto
  • Alberta Children's Hospital/University of Calgary — Calgary
  • Stollery Children's Hospital — Edmonton
  • McMaster Children's Hospital — Hamilton
  • McGill University — Montreal
  • Mount Sinai Hospital — Toronto
  • Sunnybrook Health Sciences Center — Toronto
Греция · 4 центра
  • Aghia Sofia Children's Hospital — Athens
  • University Hospital of Heraklion — Heraklion
  • Aristotle University — Thessaloniki
  • Hippokration General Hospital of Thessaloniki — Thessaloniki
Колумбия · 3 центра
  • Hospital Occidente de Kennedy — Bogotá
  • Fundacion Valle del Lili Cali — Cali
  • Clínica Universitaria Bolivariana — Medellín
Индия · 3 центра
  • St. John's Medical College Hospital — Bengaluru
  • Dr. Mehta's Hospitals — Chennai
  • Christian Medical College — Vellore
Португалия · 3 центра
  • Hospital Santa Maria, Unidade Local de Saude de Santa Maria — Lisbon
  • Centro Materno Infantil de Norte Albino Aroso, Unidade Local de Saude de Santo Antonio — Porto
  • ULS Sao Joan — Porto
Turkey (Türkiye) · 3 центра

Список центров уточняется — проверьте первичный протокол.

Австралия · 2 центра
  • The Royal Children's Hospital Melbourne — Melbourne
  • Perth Children's Hospital — Perth
Бразилия · 2 центра
  • Joana de Gusmao Children's Hospital — Florianópolis
  • Hospital de Clinicas de Porto Alegre — Porto Alegre
Чехия · 1 центр
  • Institute for the Care of Mother and Child — Prague
Германия · 1 центр
  • University of Cologne — Cologne
Венгрия · 1 центр
  • University of Szeged Children's Hospital — Szeged
Мексика · 1 центр
  • Centro de Alta Especialidad del Estado de Veracruz — Veracruz
Нидерланды · 1 центр
  • Amalia Children's Hospital Radboudumc — Nijmegen
Nigeria · 1 центр
  • University of Ibadan — Ibadan
Словения · 1 центр

Список центров уточняется — проверьте первичный протокол.

Испания · 1 центр

Список центров уточняется — проверьте первичный протокол.

Uganda · 1 центр

Список центров уточняется — проверьте первичный протокол.

Украина · 1 центр

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06823115 · 23847

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗