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Идёт набор NCT05336890

Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age

— Наблюдательное Premature Birth Asthma in Children Sleep-Disordered Breathing Neurodevelopmental Disorders

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: Premature Birth, Asthma in Children, Sleep-Disordered Breathing, Neurodevelopmental Disorders. Базовые параметры: 30 Weeks — 83 мес. · 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
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Despite improved survival of extremely premature infants in recent decades, neonatal intensive care unit (NICU) graduates are diagnosed with asthma, sleep disordered breathing (SDB) in childhood, and neurodevelopmental impairments (NDI) at significant rates, disproportionate to their term peers. Early detection and intervention are critical to mitigate the impact of these impairments. Mechanisms leading from premature birth to these undesirable outcomes remain unclear, and accurate prognostic measures are lacking. This study wants to learn if these problems are related to certain patterns of breathing that babies had while they were in the NICU.

Подробное описание

Asthma, SDB, and NDI are common consequences of preterm birth with significant impact on child and family quality of life and public health. To date, the mechanisms leading to these outcomes remain unclear, and improvements in neonatal care have not improved these outcomes. While early detection and intervention can reduce the burden of these outcomes, methods for early identification of infants destined for these morbidities is currently lacking. Utilizing the Pre-Vent cohort to investigate potential underlying causes and identify predictors for these conditions as we propose here is essential to inform future prevention and intervention strategies that promote optimal health and development.

Recent compelling data indicate that early postnatal intermittent hypoxemia (IH) events may play a role in undesirable outcomes. Early postnatal IH events in extremely preterm infants are associated with bronchopulmonary dysplasia (BPD), asthma medication at 2 years, and NDI at 18 months. The ability of IH to perturb maturation of long-term respiratory control has been demonstrated in neonatal rodents consistent with preterm infants being at heightened risk for childhood SDB. Although evidence is emerging that IH events are linked to poor outcomes in premature infants, the specific relationship between distinct IH patterns (e.g. duration, timing, frequency, and nadir) and longer-term respiratory and neurologic function remains to be elucidated.

Первичные конечные точки

  • Asthma [Срок оценки: 5 years ± 6 months of age]
  • Sleep Disordered Breathing (SDB) [Срок оценки: 5 years ± 6 months of age]
  • Neurodevelopmental Impairment (NDI) [Срок оценки: 5 years ± 6 months of age]
Вторичные конечные точки (12)
  • Respiratory Symptoms [Срок оценки: 5 yr. (+/- 6 months)]
  • Medically attended respiratory illnesses [Срок оценки: 5 yr. (+/- 6 months)]
  • Asthma Severity [Срок оценки: 5 yr. (+/- 6 months)]
  • Sleep Disordered Breathing (SDB) [Срок оценки: 5 yr. (+/- 6 months)]
  • Motor Function [Срок оценки: 5 yr. (+/- 6 months)]
  • Gross Motor Function [Срок оценки: 5 yr. (+/- 6 months)]
  • Cognitive Function [Срок оценки: 5 yr. (+/- 6 months)]
  • Executive Function [Срок оценки: 5 yr. (+/- 6 months)]
  • Social, Emotional and Behavioral Outcomes [Срок оценки: 5 yr. (+/- 6 months)]
  • Sensory Outcomes: Odor Identification [Срок оценки: 5 yr. (+/- 6 months)]
  • Sensory Outcomes: Acuity [Срок оценки: 5 yr. (+/- 6 months)]
  • Pediatric Quality of life [Срок оценки: 5 yr. (+/- 6 months)]

Критерии участия

Критерии включения

  • Enrolled in any Institutional Review Board (IRB) protocol of the Pre-Vent Study that had signed consent, or in any IRB protocol of the Pre-Vent Study that authorized re-contact for future research
  • Born <29 weeks gestational age
  • Age at enrollment less than 7 years old

Критерии исключения

  • Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason
  • Subject had no physiological data recorded as part of Pre-Vent
  • Lack of regulatory approval from local IRB or Department of Children and Family Services (DCFS) to recontact subjects
  • Adopted by non-consenting family
  • Parent refused further contact, prior to approach for Post-Vent
  • Infant enrolled in Pre-Vent at Washington University St Louis, which is not a Post-Vent participating site.

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 · 1 центр
  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago

Идентификаторы

NCT: NCT05336890 · HSR210359 · 1R01HL157256-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗