A Prospective Observational Study of Surfactant AdministrationMethods for Preterm Infants With Respiratory Distress SyndromeWith Long-term Follow-up in the Swedish Neonatal Quality Register
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mechanical ventilation or repeat surfactant within 72 hours after first surfactant treatment delivered by LISA, SALSA or INSURE method
研究概览
简要总结
The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS). Preterm infants often have immature lungs and a deficiency of surfactant, a substance that helps keep the lungs open and supports oxygen exchange.Surfactant can be delivered to the lungs using different techniques, including INSURE (brief intubation), LISA (via a thin catheter), SALSA (via a laryngeal mask airway), and traditional administration via endotracheal intubation followed by mechanical ventilation. The main question this study aims to answer is:Which method of surfactant administration is associated with better clinical outcomes in preterm infants with RDS?The study will prospectively collect clinical data on infants receiving surfactant as part of standard care, with long-term follow-up using data from the Swedish Neonatal Quality Register. The results are intended to be used to inform the design of a future randomized multicenter study.
详细描述
Background Complications of preterm birth are the leading cause of child mortality worldwide, with respiratory distress syndrome (RDS) as a major contributor. RDS is primarily caused by surfactant deficiency due to immature lungs. Early surfactant therapy, in combination with antenatal corticosteroids and non-invasive respiratory support such as continuous positive airway pressure (CPAP), is central to treatment. However, mechanical ventilation is associated with an increased risk of lung injury and bronchopulmonary dysplasia (BPD), prompting the development of less invasive surfactant administration techniques.
Surfactant Administration Methods Three main methods are currently used in spontaneously breathing preterm infants. The INSURE method involves transient intubation for surfactant delivery followed by extubation. Less Invasive Surfactant Administration (LISA) uses a thin catheter inserted below the vocal cords under laryngoscopy, allowing continued spontaneous breathing. LISA is recommended as first-line treatment in European guidelines due to improved outcomes compared to INSURE. However, both methods require laryngoscopy and are technically demanding, with potential adverse events.
Surfactant Administration via Laryngeal or Supraglottic Airways (SALSA) is a newer, less invasive technique that delivers surfactant via a supraglottic airway without laryngoscopy or passage through the vocal cords. Preliminary studies suggest comparable effectiveness to INSURE and CPAP, with potential safety advantages. Historically, SALSA has been limited to larger infants due to lack of appropriately sized devices, but newly available CE-marked devices now enable its use in extremely preterm infants.
Rationale Despite widespread use of INSURE, LISA, and SALSA, there are no direct comparisons between LISA and SALSA, and real-world data on their implementation, safety, and outcomes are limited. In Sweden, these methods are used variably across neonatal units, and their relative use and outcomes have not been systematically evaluated. The availability of smaller supraglottic airway devices now allows evaluation of SALSA in the most vulnerable population, including extremely preterm infants.
Aim The primary aim is to prospectively evaluate and compare the feasibility, safety, clinical performance, and procedural characteristics of surfactant administration methods (SALSA, LISA, INSURE) in spontaneously breathing preterm infants in a real-world clinical setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has received surfactant by any administration method
- •Gestational age below 37 weeks'
- •First surfactant treatment given before 48 hours of age
- •Confirmed or suspected diagnosis of respiratory distress syndrome (RDS)
排除标准
- •Not fulfilling above inclusion criteria
研究组 & 干预措施
LISA
Less Invasive Surfactant Administration using a thin catheter applied below the vocal cords guided by laryngoscopy
INSURE
Intubation-Surfactant-Extubation. Followed by positive pressure ventilation or brief period (<1 hour) of mechanical ventilation
SALSA
Surfactant Administration via Laryngeal or Supraglottic Airway
Group/Cohort Description: Intubation-Surfactant-Extubation. Followed by positive pressure ventilatio
Continued on mechanical ventilation >1 hour
结局指标
主要结局
Mechanical ventilation or repeat surfactant within 72 hours after first surfactant treatment delivered by LISA, SALSA or INSURE method
时间窗: Within 72 hours after first surfactant treatment
Categorical variable (Yes/No). Decision to initiate mechanical ventilation via intubation will be made at the discretion of the treating physician, guided by the local NICU criteria for mechanical ventilation. Data is extracted from medical records.
次要结局
- Bradycardia <100 bpm (any duration)(During the procedure, an average of 5-10 minutes)
- Oesophageal/upper airway injury(During and within an hour from procedure.)
- Bradycardia <60 bpm (any duration)(During the procedure, an average of 5-10 minutes)
- Desaturation to SpO₂ <80% lasting ≥30 seconds (single episode)(During the procedure, an average of 5-10 minutes)
- Duration of bradycardia <100 and <60 bpm(During the procedure, an average of 5-10 minutes)
- Duration of desaturation <80%, <60% and <40%(During the procedure, an average of 5-10 minutes)
- Surfactant-like content in gastric aspirate(Directly after first surfactant administration)
- Proportion of administered surfactant recovered in gastric aspirate(Directly after first surfactant administration)
- Surfactant reflux(Directly after first surfactant administration)
- Δ-FiO₂: Hourly change in FiO₂ from pre-procedure to 12 hours post-procedure(Within 15 minutes before the procedure to 12 hours after first surfactant administration)
- Δ-SpO2/FiO2-ratio: Change in SpO₂/FiO₂ ratio from pre-procedure to 4 hours post-procedure(Within 15 minutes before the procedure to 4 hours after first surfactant administration)
- Early failure: Mechanical ventilation within 1 hour of first surfactant administration(Within 1 hour after first surfactant administration)
- Mechanical ventilation within 72 hours of first surfactant administration(Within 72 hours after first surfactant administration)
- Repeat surfactant within 72 hours of first surfactant administration(Within 72 hours after first surfactant administration)
- Documented reason for mechanical ventilation(Within 72 hours after first surfactant administration)
- Documented reason for repeat surfactant(Within 72 hours after first surfactant administration)
- FiO2 requirement at time of intubation(Within 72 hours after first surfactant administration)
- Mechanical ventilation at any time during admission and duration(Before discharge (about 2-20 weeks))
- Total cumulative days of CPAP/NIPPV(Before discharge (about 2-20 weeks))
- Total cumulative days of mechanical ventilation (any mode)(Before discharge (about 2-20 weeks))
- Total cumulative days of nasal high flow cannula(Before discharge (about 2-20 weeks))
- Total cumulative days of any respiratory support (MV, CPAP/NIPPV, HNFC, or oxygen cannula)(Before discharge (about 2-20 weeks))
- FiO2 requirement before repeat surfactant(Within 72 hours after first surfactant administration)
- Time to repeat surfactant(Before discharge (about 2-20 weeks))
- Time to mechanical ventilation(Before discharge (about 2-20 weeks))
- Total cumulative days of mechanical ventilation, conventional(Before discharge (about 2-20 weeks))
- Total cumulative days of supplemental O2(Before discharge (about 2-20 weeks))
- Systemic (oral or intravenous) steroid treatment due to lung disease(Before discharge (about 2-20 weeks))
- Death(Before discharge (about 2-20 weeks))
- Time to death(Before discharge (about 2-20 weeks))
- Cause of death(Before discharge (about 2-20 weeks))
- Intraventricular heamorrhage (IVH)(Before discharge (about 2-20 weeks))
- Highest grade of IVH, any side(Before discharge (about 2-20 weeks))
- Post-haemorrhagic ventricular dilatation (PHVD)(Before discharge (about 2-20 weeks))
- Cystic periventricular leukomalacia (cPVL)(Before discharge (about 2-20 weeks))
- Bronchopulmonary dysplasia (BPD)(Before discharge (about 2-20 weeks))
- Severe BPD(Before discharge (about 2-20 weeks))
- Pneumothorax(Before discharge (about 2-20 weeks))
- Thoracic drain(Before discharge (about 2-20 weeks))
- Early Onset Sepsis, culture verified(Before discharge (about 2-20 weeks))
- Early Onset Sepsis, clinical diagnosis(Before discharge (about 2-20 weeks))
- Late Onset Sepsis, culture verified(Before discharge (about 2-20 weeks))
- Late Onset Sepsis, clinical diagnosis(Before discharge (about 2-20 weeks))
- Necrotizing Enterocolitis (NEC)(Before discharge (about 2-20 weeks))
- NEC with perforation(Before discharge (about 2-20 weeks))
- NEC with surgical treatment(Before discharge (about 2-20 weeks))
- Spontaneous intestinal perforation(Before discharge (about 2-20 weeks))
- Persistent ductus arteriosus (PDA), medical treatment(Before discharge (about 2-20 weeks))
- PDA requiring, surgical treatment(Before discharge (about 2-20 weeks))
- Examined for retinopathy of prematurity (ROP)(Before discharge (about 2-20 weeks))
- Maximim ROP any side, grade(Before discharge (about 2-20 weeks))
- ROP ≥ grade 3(Before discharge (about 2-20 weeks))
- ROP treatment(Before discharge (about 2-20 weeks))
- Major neonatal morbidity(Before discharge (about 2-20 weeks))
- Weight at discharge(Before discharge (about 2-20 weeks))
- Δ-weight at discharge(Before discharge (about 2-20 weeks))
- Supplemental oxygen at discharge from hospital(Before discharge (about 2-20 weeks))
- Duration of admission (in-patient care)(Before discharge (about 2-20 weeks))
- Asthma or obstructive respiratory symptoms during the past 12 months(Follow-up at 2 years of age)
- Treatment for above obstructive symptoms during the past 12 months(Follow-up at 2 years of age)
- Speech and language development(Follow-up at 2 years of age)
- Visual impairment(Follow-up at 2 years of age)
- Visual impairment, left; right(Follow-up at 2 years of age)
- Hearing impairment(Follow-up at 2 years of age)
- Hearing impairment, left; right(Follow-up at 2 years of age)
- Bayley score (all scores for all categories)(Follow-up at 2 years of age)
- Assessed as normal development at follow-up(Follow-up at 2 years of age)
- Assessed as not normal in following area(Follow-up at 2 years of age)
- Seizure disorder(Follow-up at 2 years of age)
- Hydrocephalus(Follow-up at 2 years of age)
- Cerebral paresis(Follow-up at 2 years of age)
- Gross motor function scale(Follow-up at 2 years of age)
- Any new diagnoses after discharge(Follow-up at 2 years of age)
- Asthma or obstructive respiratory symptoms during the past 12 months(Follow-up at 5,5 years of age)
- Treatment for above during the past 12 months(Follow-up at 5,5 years of age)
- Visual impairment(Follow-up at 5,5 years of age)
- Visual impairment, left(Follow-up at 5,5 years of age)
- Visual impairment, right(Follow-up at 5,5 years of age)
- Hearing impairment(Follow-up at 5,5 years of age)
- Hearing impairment, left(Follow-up at 5,5 years of age)
- Hearing impairment, right(Follow-up at 5,5 years of age)
- Speech and language development(Follow-up at 5,5 years of age)
- Seizure disorder(Follow-up at 5,5 years of age)
- Hydrocephalus(Follow-up at 5,5 years of age)
- Cerebral paresis(Follow-up at 5,5 years of age)
- Gross motor function scale(Follow-up at 5,5 years of age)
- Manual abilities classification system(Follow-up at 5,5 years of age)
- WIPPSI, (all scores for all categories)(Follow-up at 5,5 years of age)
- Strengths and difficulties questionnaire (SDQ) scores(Follow-up at 5,5 years of age)
- Any new diagnoses after discharge(Follow-up at 5,5 years of age)
- Assessed as normal development at follow-up(Follow-up at 5,5 years of age)
- Assessed as not normal in following area(Follow-up at 5,5 years of age)