No registrations found.
ID
Source
Brief title
Health condition
Prematurity, Wheezing, Respiratory Tract Infections
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total number of physician diagnosed lower RTI and wheezing episodes in the first 18 months of life.
Secondary outcome
• time to first lower RTI or wheezing episode
• total number of RTI
• total number of wheezing episodes
• distribution of viruses (in case of hospital admission)
• medication use (bronchodilators, corticosteroids, antibiotics)
• lung function as measured by expiratory variability index
• comparison of expiratory variability index in moderate/late prematurity compared to term cohort
• correlation between expiratory variability index and other pulmonary function analyses
• association between expiratory variability index and number of RTI/wheezing
• outdoor air quality
• indoor air quality
• association between air quality and number of RTI
• quality of life
• classification of high risk patients
• costs- and cost-effectiveness
Background summary
Rationale: Approximately 8% of all births occur between 30-36 weeks of pregnancy (‘moderate-late’ prematurity) and is associated with the development of chronic obstructive lung disease later in life. Respiratory tract infections (RTI) and wheezing illnesses disproportionally affect preterms in early life resulting in frequent hospitalisation. Besides prematurity, several other modifiable influencing factors are associated with impaired pulmonary development: respiratory tract infections (RTI), local air pollution, tobacco smoke exposition, vitamin D deficiency, maternal stress and antibiotic usage.
Objectives: To identify and treat modifiable influencing factors negatively affecting pulmonary health in moderate-late preterms during the first 18 months of life using an innovative multidisciplinary follow-up framework.
Study objective
We envision that a standardized follow-up framework designed to better monitor pulmonary health in moderate-late preterm infants will reduce respiratory disease and related healthcare consumption. The identification and preventive treatment of modifiable influencing factors and early detection of abnormal pulmonary function in a unique follow-up framework will substantially improve pulmonary health and prevent suboptimal pulmonary development.
Study design
T 3,6,12 and 18 months
Intervention
LONG LOVE Framework
Inclusion criteria
• Gestational age at delivery between 30+0 and 35+6 weeks
• Written informed consent by both parents or formal caregivers
Exclusion criteria
• Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group) ; diaphragmatic hernia; other serious congenital lung disorders; hemodynamic significant cardiac disease; immunodeficiency; severe failure to thrive; birth asphyxia with predicted poor neurological outcome; syndromic or serious congenital disorders.
• Parents unable to speak and read the Dutch or English language
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9688 |
| Other | METC MEC-U : XXXXXXXXXXXX |