Towards Life-Long Healthy Lungs: A Multidisciplinary Follow-up Framework for Preterm Infants (Dutch: Naar Levenslang Gezonde LONGen: Een multidiscipLinair zOrgpad Voor te Vroeg Geboren kindEren)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Number of lower Respiratory Tract Infections (RTI)
研究概览
简要总结
Approximately 8% of all births occur between 30-36 weeks of gestation ('moderate-late' prematurity). Respiratory tract infections (RTI) and wheezing illnesses disproportionally affect preterm infants resulting in a 1.5-2 fold higher hospitalisation rate during the first years of life compared to term born children. Besides prematurity, several other postnatal modifiable influencing factors are associated with increased risk of respiratory morbidity and impaired pulmonary development. These factors include RTI, rapid weight gain, air pollution, tobacco smoke exposition, vitamin D deficiency, maternal stress and antibiotic usage. The investigators hypothesize that a follow-up program aiming at prevention of modifiable influencing factors can reduce respiratory morbidity in moderate and late prematurity. Objectives: To reduce respiratory disease burden in moderate-late preterm infants in the first 18 months of life
详细描述
Background of the study:
Approximately 8% of all births occur between 30-36 weeks of gestation (moderate-late prematurity). Respiratory tract infections (RTI) and wheezing illnesses disproportionally affect preterms, resulting in a 1.5-2 fold higher hospitalization rate during the first years of life compared to term-born children. Besides prematurity, several other modifiable influencing factors are associated with increased risk of respiratory morbidity and impaired pulmonary development. These factors include rapid weight gain and obesity at an early age, tobacco smoke exposure, air pollution, microbiome composition, and recurrent RTI.
To promote optimal lung health and development in moderate-late preterm infants, increased respiratory health surveillance and protection against RTI in early life might be crucial. Previous research has shown that the introduction of a multidisciplinary follow-up framework in children with bronchopulmonary dysplasia resulted in a significant reduction in hospital readmissions.
Despite the burden of respiratory disease, moderate to late preterms do not currently receive standardised respiratory follow-up care. With LONG LOVE, the investigators introduce a novel follow-up framework tailored for preterms and designed to improve respiratory health. As the risk of the onset of pulmonary disease is further increased by postnatal factors such as tobacco smoke exposure, air pollution and RTI, our main focus is the detection and treatment of these modifiable influencing factors. LONG LOVE incorporates eHealth and new technology in order to measure pulmonary function and air quality. Intervention strategies include counseling on nutrition, lifestyle, medication, and improving indoor air quality.
Objective of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate-late preterm infants (GA 30+0 - 35+6 weeks)
排除标准
- •bronchopulmonary dysplasia (BPD)
- •congenital diaphragmatic hernia (CHD),
- •congenital pulmonary disorders
- •hemodynamic significant cardiac disease
- •immunodeficiency
- •severe failure to thrive;
- •birth asphyxia with poor neurological outcome
- •syndromic or other severe congenital disorders with decreased life expectancy
结局指标
主要结局
Number of lower Respiratory Tract Infections (RTI)
时间窗: 18 months of life
Total number of physician diagnosed lower RTI
Number of wheezing episodes
时间窗: 18 months of life
Total number of physician diagnosed wheezing episodes
次要结局
- time to first lower RTI or wheezing episode(18 months of life)
- total number of RTI(18 months of life)
- total number of wheezing episodes(18 months of life)
- distribution of viruses (in case of hospital admission)(18 months of life)
- medication use(18 months of life)
- lung function as measured by expiratory variability index (EVI)(3, 6, 12 months of age)
- comparison of expiratory variability index in moderate/late prematurity compared to term cohort (reference cohort from other center)(3, 6, 12 months of age)
- correlation between expiratory variability index and Lung Capacity Index and Hypoxic Challenge Test(6 months of age)
- association between expiratory variability index and number of RTI/wheezing(18 months of life)
- Analysis of outdoor air quality(12 months)
- indoor air quality(12 months)
- Preschool Children Quality of Life(12 and 18 months of life)
- Total costs of framework(18 months of life)
- Care-related Quality of Life(18 months of life)
- Cost-effectiveness of framework(18 months of life)