To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations on the Clinical Outcomes of Very Preterm Infants Under Non-invasive Assisted Ventilation

Обзор

A prospective multicenter randomized controlled study was conducted. Eligible very preterm infants with a gestational age of \<32 weeks were enrolled. All infants received routine treatment after birth and were randomly divided into two groups according to the FiO2 threshold of PS under noninvasive assisted ventilation: Control group (FiO2=0.30) and low concentration group (FiO2=0.25). Clinical data were collected to explore the differences in clinical outcomes between the two groups.

Подробное описание

① All the very/extremely preterm infants who met the criteria were divided into low concentration group and high concentration group according to the random number table method. The pressure, respiratory rate and other parameters were set according to the relevant clinical guidelines or expert consensus. The initial FiO2 was 21% when PEEP was ≥6 cmH2O. To maintain SpO2 90%-94%. According to the FiO2 threshold corresponding to randomization, PS treatment was given when FiO2 reached the threshold (the initial dose was 200mg/kg, and the second or third dose of 100mg/kg could be repeated if necessary if the disease progressed). PS treatment was administered as early as possible within 6 hours after birth. Endotracheal intubation, INSURE technique, or LISA technique can be used.

② The basic information and perinatal outcomes of the two groups were collected; Outcome indicators: the main outcome indicators were the failure rate of non-invasive treatment, the time of tracheal intubation mechanical ventilation, the time of non-invasive assisted ventilation, the days of oxygen therapy, the time of the first use of PS, and the rate of repeated PS. The secondary outcomes included mortality, incidence of BPD, incidence of ROP, oxygen demand at 28 days after birth and 36 weeks of corrected gestational age, oxygen demand at discharge, length of hospital stay, and cost of hospitalization.

Вмешательства

• Другое According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold
  According to the relevant clinical guidelines or expert consensus, the pressure, respiratory rate and other parameters were set. The initial FiO2 was 21% when PEEP was ≥6 cmH2O. FiO2 was adjusted according to the respiration and percutaneous oxygen saturation (SpO2) of the children. To maintain SpO2 90%-94%. According to the FiO2 threshold corresponding to randomization, PS treatment was given when FiO2 reached the threshold (the initial dose was 200mg/kg, and the second or third dose of 100mg/k

Первичные конечные точки

• Duration of tracheal intubation and mechanical ventilation [Срок оценки: The children required tracheal intubation and mechanical ventilation during hospitalization, and the observation time was about 2 months]
• Time of first PS use [Срок оценки: Time to first use of pulmonary surfactant within 6 hours after birth]
• Duration of noninvasive assisted ventilation [Срок оценки: Noninvasive ventilation was required during hospitalization, and the observation time was about 2 months]
• Repeat PS usage rate [Срок оценки: The frequency of repeated use of pulmonary surfactant during hospitalization was observed for about 1 week after birth]
• Days of Oxygen therapy [Срок оценки: The children needed oxygen inhalation for a number of days during hospitalization, and the observation time was about 2 months]
• Failure rate of noninvasive treatment [Срок оценки: 72 hours after birth]

Критерии участия

Критерии включения

• Very preterm infants with gestational age <32 weeks
• immediately transferred to the neonatal intensive care unit
• signs of respiratory distress or RDS requiring respiratory support;
• Informed consent was obtained from the families of the children.

Критерии исключения

• Giving up treatment or being transferred to other hospitals during hospitalization;
• requiring mechanical ventilation with tracheal intubation immediately or within 2 hours after birth
• complicated with pneumothorax, complex congenital heart disease, congenital malformation, congenital cystic lung disease, chromosomal inherited metabolic diseases, etc
• Incomplete clinical data

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Third Affiliated Hospital of Zhengzhou University — Henan

Идентификаторы

NCT: NCT07235345 · 2025-242-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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