Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Официальное название

Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa

Обзор

The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are: Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique? Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant. Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will: Receive surfactant replacement therapy by the less invasive surfactant administration technique. Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.

Подробное описание

The low- and middle-income countries of Sub-Saharan Africa (SSA) carry the highest burden of preterm births and deaths. A primary driver of preterm mortality in SSA is respiratory distress syndrome. Surfactant replacement therapy by the less invasive surfactant administration (LISA) is a technique where the surfactant is administered to a preterm neonate with respiratory distress syndrome managed on continuous positive airway pressure (CPAP), reducing the need for using an invasive mechanical ventilator. In high-income countries, LISA has been shown to be effective in reducing the need for invasive mechanical ventilators and mortality. However, the impact of LISA is unknown in low-resourced settings without ventilators.

The central hypothesis is that implementing LISA in newborn units that care for preterm neonates using standardized CPAP and caffeine citrate will improve survival in preterm neonates.

PICO Outline:

Population: Preterm neonates 750 and 2000 grams or gestational age between 24- and 35 weeks at birth with respiratory distress defined by a Silverman Anderson Score of ≥5, who are spontaneously breathing and on CPAP.

Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.

Comparator: Standard of care - standardized CPAP and Caffeine.

Outcome measures: Primary Outcome: All-cause in-hospital survival.

Вмешательства

• Препарат Surfactant
  Surfactant is instilled into the lungs through a thin catheter passed into the trachea during laryngoscopy while on continuous positive airway pressure (CPAP)

Первичные конечные точки

• Hospital Survival [Срок оценки: Through hospitalization, an average of 6 months]

Вторичные конечные точки (3)

• Incidence of major preterm neonatal morbidity [Срок оценки: Through hospitalization, an average of 6 months]
• The incidence of pneumothorax [Срок оценки: Through hospitalization, an average of 6 months]
• Hospital survival at seven day [Срок оценки: 7 days following birth]

Критерии участия

Критерии включения

• Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.
• Silverman Anderson Score ≥5 before or after CPAP treatment.
• Admitted to a study site within 24 hours of life.

Критерии исключения

• Major congenital or genetic anomalies.
• Active pulmonary hemorrhage.
• Major craniofacial anomalies that preclude the successful use of CPAP

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Ghana · 3 центра

• Korle-Bu Teaching Hospital — Accra
• Komfo Anokye Teaching Hospital — Kumasi
• Tamale Teaching Hospital — Tamale

Kenya · 2 центра

• Coast General Teaching & Referral Hospital — Mombasa
• Mama Lucy Kibaki Hospital — Nairobi

Nigeria · 2 центра

• Federal Teaching Hospital Ido-Ekiti — Ido-Ekiti
• University of Ilorin Teaching Hospital — Ilorin

Central African Republic · 1 центр

• Centre Hospitalier Universitaire Communautaire — Bangui

Идентификаторы

NCT: NCT06554522 · 22326

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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