Набор скоро начнётся NCT07315594

Initial Oxygen Concentration at Birth in Late-Preterm Infants

Без фазы С лечением Preterm Birth

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: В протоколе указаны: 60% Oxygen Group - Infants will start in 60% oxygen, 30% Oxygen Group - Infants will start in 30% oxygen.
Кому может быть актуально: Состояния в реестре: Preterm Birth. Базовые параметры: 0 Minutes — 10 Minutes · 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: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cluster Randomized Trial of Initial Oxygen Concentration at Birth in Late-Preterm Infants

Обзор

This study is aims to examine the best amount of oxygen to give preterm babies (born between 32 and 35 weeks) right after birth. In the past, doctors used high levels of oxygen, but research has shown that using lower levels might help reduce the risk of death in full-term babies without harming brain development. However, investigators don't know the best oxygen level for babies born a little early (32 to 35 weeks). Some early data suggests that giving lower oxygen levels (FiO2 0.3) may not help babies reach healthy oxygen levels by 5 minutes after birth. This study will compare two oxygen levels-FiO2 0.6 and FiO2 0.3 to see which helps babies breathe better and need less ongoing breathing support. Researchers will study over 1,500 babies in hospitals across Alberta, Canada, to find the safest approach for these babies.

Вмешательства

Препарат 60% Oxygen Group - Infants will start in 60% oxygen
Infants randomized to the 60% Oxygen (FiO₂) Group will begin respiratory support with an initial inspired oxygen concentration of 60%. At birth, all infants will receive 60 seconds of delayed cord clamping as standard care. Following cord clamping, a pulse oximeter will be applied to measure peripheral oxygen saturation (SpO₂), with a reliable signal typically available at approximately 3 minutes of age. At 3 minutes of age, the clinical team will assess SpO₂. If SpO₂ is \<85%, the inspired oxy
Препарат 30% Oxygen Group - Infants will start in 30% oxygen
Infants randomized to the 30% Oxygen (FiO₂) Group will begin respiratory support with an initial inspired oxygen concentration of 30%. At birth, all infants will receive 60 seconds of delayed cord clamping as standard care. Following cord clamping, a pulse oximeter will be applied to measure peripheral oxygen saturation (SpO₂), with a reliable signal typically available at approximately 3 minutes of age. At 3 minutes of age, the clinical team will assess SpO₂. If SpO₂ is \<85%, the inspired oxy

Первичные конечные точки

Need for ongoing respiratory support at one hour after birth [Срок оценки: first 60 minutes after birth]

Вторичные конечные точки (4)

Mortality in the delivery room [Срок оценки: first 60 minutes after birth]
Mortality prior discharge [Срок оценки: up to 100 days after birth]
Duration of hospital stay [Срок оценки: up to 100 days]
Air leak [Срок оценки: first 72 hours after birth]

Критерии участия

Критерии включения

i) Infants with gestational age between 32+0-35+6 weeks based on best available obstetrical estimate, requiring respiratory support
ii) Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to provide only comfort care at birth
iii) No known major congenital or chromosomal malformation.