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| Name | Class |
|---|---|
| Jiangxi Maternal and Child Health Hospital | OTHER |
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This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm infants with respiratory distress syndrome (RDS) reduces noninvasive ventilation failure rates (primary outcome: intubation requirement), compared to the standard threshold (FiO₂ >0.3). By establishing the clinical superiority of early PS administration, this study aims to refine evidence-based guidelines for RDS management in preterm neonates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower oxygen threshold group (FiO₂ >0.25) | Experimental | Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.25 |
|
| Higer oxygen threshold group (FiO₂ >0.3) | Active Comparator | Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Threshold FiO₂ | Procedure | Group 1 (Intervention Group) received the initial dose of pulmonary surfactant immediately upon reaching an inhaled oxygen concentration (FiO₂) >0.25. Group 2 (Control Group) received the initial dose of pulmonary surfactant as early as possible within 48 hours, but only when FiO₂ was titrated to >0.3 based on the infant's clinical condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth | 72 hours after birth |
| Measure | Description | Time Frame |
|---|---|---|
| The requirement for repeated pulmonary surfactant administration, including the total number of doses utilized | 7 days after birth | |
| BPD, defined according to the NICHD definition | 3 months after birth |
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Inclusion Criteria:
(1) Gestational Age: 26 weeks +0 day to 31 weeks+6days at birth (inclusive). (2) Clinical Diagnosis of NRDS: Symptoms: Tachypnea, grunting, and/or progressive respiratory distress. Imaging Findings: Chest X-ray showing at least one of: Ground-glass opacity, Air bronchograms, Diffuse "white lung" pattern, Lung Ultrasound (recommended).
(3) Admission to NICU within 3 hours of birth. Requirement for non-invasive nasal intermittent positive pressure ventilation (NIPPV) at enrollment.
(4) Signed informed consent obtained from parent(s) or legal guardian(s).
Exclusion Criteria:
Invasive mechanical ventilation during delivery or transport to NICU.
Structural upper airway abnormalities precluding non-invasive ventilation.
Confirmed diagnosis of major congenital malformations
Endotracheal intubation for indications unrelated to NRDS (e.g., surgery, sepsis management)
Initiation of non-invasive ventilation >3 hours post-birth.
Voluntary discharge or treatment withdrawal within 72 hours post-enrollment.
Parental/guardian refusal to Sign informed consent or Authorize surfactant administration
Incomplete clinical records or missing key outcome variables
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Shi, PhD | Contact | 0791-86224432 | shiyuan@hospital.cqmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangxi Maternal and Child Health Hospital | Nanchang | Jiangxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41213831 | Derived | Yang R, Fang Z, Liu KZ, Zhu X, Ding XP, Luo Q, Zhou WJ, Hu XW, Zhou JL, Tang WY, Shi Y. Comparison of two fractions of inspired oxygen thresholds (0.25 vs 0.30) for surfactant administration in very preterm infants with respiratory distress syndrome under nasal intermittent positive pressure ventilation: study protocol for a multicentre randomised controlled, superiority trial. BMJ Paediatr Open. 2025 Nov 10;9(1):e003998. doi: 10.1136/bmjpo-2025-003998. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D006819 | Hyaline Membrane Disease |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012127 | Respiratory Distress Syndrome, Newborn |
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| airleaks occurred after the extubation | 3 months after birth |
| retinopathy of prematurity (ROP) > 2nd stage | 3 months after birth |
| necrotizing enterocolitis (NEC) ≥ 2nd stage | 3 months after birth |
| IVH > 2nd grade | 3 mionths after birth |
| hemodynamically significant patent ductus arteriosus (PDA) | 3 months after birth |
| weekly weight gain (in grams/d) for the first 4 weeks of life or until NICU discharge, whichever comes first. | 3 months after birth |
| Duration of non-invasive respiratory support | 3 months after birth |
| total hospitalization cost | 6 months after birth |
| nasal skin injury | 3 months after birth |
| in-hospital mortality | 6 months after birth |
| ventilator-free days | 3 months after birth |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |