A follow-up program for improving lung health in preterm infants
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)
NA · Franciscus Gasthuis · NCT05618769
This study is testing a new follow-up program to help improve lung health in preterm infants by addressing issues that can harm their breathing in the first 18 months of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Sex | All |
| Sponsor | Franciscus Gasthuis (other) |
| Locations | 1 site (Rotterdam, Zuid-Holland) |
| Trial ID | NCT05618769 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a multidisciplinary follow-up framework for moderate-late preterm infants to reduce respiratory morbidity in their first 18 months of life. It focuses on identifying and mitigating modifiable risk factors such as respiratory tract infections, rapid weight gain, and environmental exposures that can impair lung development. The intervention, known as the LONG LOVE Framework, seeks to provide tailored respiratory health surveillance and care, which is currently lacking for this population. By addressing these factors, the study hopes to improve overall respiratory health outcomes for preterm infants.
Who should consider this trial
Good fit: Ideal candidates for this study are moderate-late preterm infants born between 30 and 36 weeks of gestation.
Not a fit: Patients with bronchopulmonary dysplasia or other severe congenital disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of respiratory diseases in moderate-late preterm infants.
How similar studies have performed: Previous studies have shown success with multidisciplinary follow-up frameworks in similar populations, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Moderate-late preterm infants (GA 30+0 - 35+6 weeks) Exclusion Criteria: * 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
Where this trial is running
Rotterdam, Zuid-Holland
- Franciscus Gasthuis & Vlietland — Rotterdam, Zuid-Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Gerdien Tramper, MD, PhD — Franciscus Gasthuis & Vlietland
- Study coordinator: Kishan Tsang, MD
- Email: k.tsang@franciscus.nl
- Phone: +31(0)683278272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Birth, Respiratory Disease, Respiratory Tract Infections, Preterm Birth, Bronchopulmonary Dysplasia, Pollution Related Respiratory Disorder, Pollution, Exposure