Towards Life-Long Healthy Lungs: A Multidisciplinary Follow-up Framework for Preterm Infants

NCT05618769 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2022-11-16

No results posted yet for this study

Summary

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

Conditions

  • Premature Birth
  • Respiratory Disease
  • Respiratory Tract Infections
  • Preterm Birth
  • Bronchopulmonary Dysplasia
  • Pollution Related Respiratory Disorder
  • Pollution; Exposure
  • Smoking Cessation
  • Health-Related Behavior
  • RSV Infection
  • RSV Pneumonia
  • Bronchial Hyperreactivity
  • Telemedicine
  • eHealth

Interventions

COMBINATION_PRODUCT

LONG LOVE Framework

In order to identify modifiable influencing factors, clinical data of the infants included in our multidisciplinary framework will be continuously collected by eHealth (Luscii Healthtech BV, Netherlands). Study visits take place at 1-1,5 3, 6, 12 and 18 months of age. Outdoor air quality measurements will be conducted using RIVM Luchtmeetnet. Indoor air quality measurements will be collected during a period of 6 weeks using a commercial available device. Lung function analysis using impedance pneumatography (Ventica Recorder, Revenio Research LTD, Finland) will take place during 2 nights at 3, 6 and 12 months of age. In the event of modifiable influencing factors medical or lifestyle interventions will be undertaken.

Sponsors & Collaborators

  • Stichting BeterKeten

    collaborator UNKNOWN
  • Revenio Research

    collaborator INDUSTRY
  • Chiesi Farmaceutici S.p.A.

    collaborator INDUSTRY
  • Franciscus Gasthuis

    lead OTHER

Principal Investigators

  • Gerdien Tramper, MD, PhD · Franciscus Gasthuis & Vlietland

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2025-06-30
Completion
2025-07-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05618769 on ClinicalTrials.gov