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| Name | Class |
|---|---|
| Zhumadian Central Hospital | OTHER |
| Zhengzhou Central Hospital | OTHER |
| Xinyang Central Hospital | OTHER |
| Xinxiang Central Hospital |
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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.
①All 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.
â‘¡ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High fraction of inspired oxygen | No Intervention | Parameters such as pressure and respiratory rate were set according to relevant clinical guidelines or expert consensus. The initial FiO2 was 21% when PEEP was ≥6 cmH2O, and FiO2 was adjusted according to the respiration and percutaneous oxygen saturation (SpO2) of the children to maintain SpO2 90%-94%. When FiO2 reached 30%, PS treatment was given (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 should be given as early as possible within 6 hours after birth. Endotracheal intubation, INSURE technique, or LISA technique can be used. | |
| Low fraction of inspired oxygen | Experimental | Parameters such as pressure and respiratory rate were set according to relevant clinical guidelines or expert consensus. The initial FiO2 was 21% when PEEP was ≥6 cmH2O, and FiO2 was adjusted according to the respiration and percutaneous oxygen saturation (SpO2) of the children to maintain SpO2 90%-94%. PS was given when FiO2 reached 25% (the initial dose was 200mg/kg, and the second or third dose of 100mg/kg could be given if necessary if the disease progressed), and PS was administered as early as possible within 6 hours after birth. Endotracheal intubation, INSURE technique, or LISA technique can be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold | Other | 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/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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of tracheal intubation and mechanical ventilation | The duration of invasive mechanical ventilation was observed | The children required tracheal intubation and mechanical ventilation during hospitalization, and the observation time was about 2 months |
| Time of first PS use | The time from the first use of PS to birth was observed | Time to first use of pulmonary surfactant within 6 hours after birth |
| Duration of noninvasive assisted ventilation | The duration of noninvasive mechanical ventilation was observed during hospitalization | Noninvasive ventilation was required during hospitalization, and the observation time was about 2 months |
| Repeat PS usage rate | Whether PS was used repeatedly during hospitalization was observed | The frequency of repeated use of pulmonary surfactant during hospitalization was observed for about 1 week after birth |
| Days of Oxygen therapy | The time of oxygen therapy during hospitalization was observed | 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 | The use of invasive mechanical ventilation after birth was observed | 72 hours after birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Zhengzhou University | Henan | Zhengzhou | 455000 | China |
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| OTHER |
| Nanyang Central Hospital | OTHER |
| Zhoukou Central Hospital | OTHER |
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|
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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