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

NCT05618769 | Unknown

• 1 other identifier: 2021-117
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Moderate preterm; Late preterm; Post-Prematurity Respiratory Disease; Prematurity Associated Lung Disease; eHealth; mHeath; Follow-up; Respiratory Disease; Air pollution; Value Based Health Care

Outcome Measures

Primary Outcomes (2)

• Number of lower Respiratory Tract Infections (RTI)

  Total number of physician diagnosed lower RTI

  18 months of life

• Number of wheezing episodes

  Total number of physician diagnosed wheezing episodes

  18 months of life

Secondary Outcomes (15)

• 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

Study Arms (2)

Intervention (LONG LOVE Framework)

EXPERIMENTAL

Consists of participants born in Franciscus Gasthuis (FG) and/or Vlietland (FV) and will be allocated to the intervention group, receiving additional (in addition to current standard of care) follow-up in accordance with our newly developed framework to identify modi able influencing factors compromising pulmonary health using validated questionnaires, weekly monitoring of respiratory symptoms as reported by parents using an app, in- and outdoor air quality measurements and non-invasive pulmonary function measurements based on impedance pneumatography. In case of any modi able influencing factors, appropriate lifestyle and/or medical interventions will be undertaken.

Combination Product: LONG LOVE Framework

Control

NO INTERVENTION

Consist of participants born in Maasstad Ziekenhuis (MSZ) and Albert Schweitzer Ziekenhuis (ASZ) and will receive standard of care follow-up. Parents are requested to provide informed consent for the registration of outcome measurements and requested to complete validated questionnaires. Data on utilization of medical services will be inquired to avoid recall bias.

Interventions

LONG LOVE Framework COMBINATION_PRODUCT

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.

Intervention (LONG LOVE Framework)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate-late preterm infants (GA 30+0 - 35+6 weeks)

You may not qualify if:

• 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

Sponsors & Collaborators

• Franciscus Gasthuis: lead
• Stichting BeterKeten: collaborator
• Revenio Research: collaborator
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (1)

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045 PM, Netherlands

RECRUITING

MeSH Terms

Conditions

Premature Birth; Respiration Disorders; Respiratory Tract Infections; Bronchopulmonary Dysplasia; Smoking Cessation; Health Behavior; Respiratory Syncytial Virus Infections; Bronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Tract Diseases; Infections; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Bronchial Diseases

Study Officials

• Gerdien Tramper, MD, PhD

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kishan Tsang, MD

CONTACT

+31(0)683278272; k.tsang@franciscus.nl

Gerdien Tramper, MD, PhD

CONTACT

+31(10)4617126; g.tramper@franciscus.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental design based on a non-randomized cluster trial, in which moderate-late preterm born infants will be allocated to the intervention or control group based on location of neonatal care. This design was chosen based on the limited amount of participating clusters and feasibility. As a quasi-experimental design can result in confounding by cluster and to increase internal validity, subjects of the control and intervention groups will be demographically matched at baseline

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: November 16, 2022
• Study Start: July 18, 2022
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: November 16, 2022

Record last verified: 2022-09

Locations

NL (1)