Long-Term Burden of BPD and Health-Related Quality of Life (BronQ Family)

NCT07134387 | Recruiting

• 1 other identifier: METC 2025-0285
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to examine the long-term impact of having a child with Bronchopulmonary Dysplasia (BPD) on the parents and caregivers from the time of diagnosis through adulthood. The primary focus will be on parents and caregivers of children until the age of 18 (\< 18) years who were diagnosed with BPD as newborns. Data will be collected through an online questionnaire in France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland), and the United States. It will ask about inclusion and exclusion criteria, background information (caregiver, child, and family situation), the child's medical situation, parental health-related quality of life (HRQoL), health literacy, feelings, support structures, and economic burden of the family.

Conditions

Bronchopulmonary Dysplasia (BPD); Chronic Lung Disease of Newborn; HRQOL (Health Related Quality Of Life)

Keywords

Parental Quality of life; QoL; Health-related quality of life; HRQoL; Caregiver burden; Parental well-being; Family; Bronchopulmonary Dysplasia (BPD); Chronic Lung Disease (CLD); Chronic Lung Diseaseof Newborn; Respiratory Morbidity; Long-term outcomes; Parents; Caregivers; Infants; Newborn; Children; Preterm; Prematurity; NICU; Intensive Care; Neonatal; Survey; Questionnaire; Multinational study; retrospective data collection; participatory research; Patient-reported outcomes; PROs; Patient-reported outcome measures; PROMs

Outcome Measures

Primary Outcomes (1)

• Parental health-related quality of life (HRQoL) assesed by Pediatric Quality of Life Inventory, Family Impact Module (PedsQL FIM)

  To record the parents' HRQoL, the Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) is implemented, a validated and widely used instrument designed to measure the impact of pediatric acute and chronic health conditions on parents and the family. It consists of 36 items across six parental dimensions (physical, emotional, social, and cognitive functioning, communication, and worry), as well as family daily activities and relationships. It is validated in all official languages of the seven participating countries (English, French, German, Italian, Dutch, Spanish) and allows the calculation of a sum score.

  09/2025 - 02/2026

Secondary Outcomes (5)

• Participant characteristics assesed by self developed online questionnaire

  09/2025 - 02/2026

• Medical Situation of the child assesed by self developed online questionnaire (parent report)

  09/2025 - 02/2026

• Economic burden on families (Quantitative and qualitative) assesed by adapted version of the Family Economic Impact Inventory (Domain Family Finances)

  09/2025 - 02/2026

• Health Literacy (Quantitative) assesed by self-developed online questionnaire

  09/2025 - 02/2026

• Support Structures (Quantitative and qualitative) assesed by self developed online questionnaire

  09/2025 - 02/2026

Study Arms (2)

Parents or caregivers of children with (a history of) physician diagnosed BPD

The primary population of this study consists of parents and caregivers of preterm born children (\< 37 weeks of gestation) under 18 years old who have been diagnosed with newborn-onset Bronchopulmonary Dysplasia (BPD). Furthermore, the child should have been discharged from their initial hospital stay after birth. Participants will be recruited from multiple countries, including France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland), and the United States.

Other: N/A, no intervention, participation in survey

Parents or caregivers of preterm born children without chronic health conditions

The control group consists of parents and caregivers of preterm born children (\< 37 weeks of gestation) under 18 years old who do not report a history of BPD. Furthermore, the child should have been discharged from their initial hospital stay after birth. They will as well be recruited from France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland), and the United States. If the final sample size permits, a post hoc filter will be applied to restrict analyses to the subgroup of very preterm (\< 32 weeks gestation) and/or very low birthweight (\< 1500 g birthweight) children.

Other: N/A, no intervention, participation in survey

Interventions

N/A, no intervention, participation in survey OTHER

A unified questionnaire will be utilized for all participants, irrespective of their group assignment. Participants will be assigned to the BPD or comparison group retrospectively, based on their answers defining the BPD-status. To enhance comprehension, the questionnaire avoids using the term "BPD" wherever feasible and instead employs a more general reference to lung problems.

Parents or caregivers of children with (a history of) physician diagnosed BPD; Parents or caregivers of preterm born children without chronic health conditions

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of parents and caregivers of preterm-born children under 18 years old who have already been discharged from their initial hospital stay. Participants will be recruited from multiple countries, including France, Germany, Italy, the Netherlands, Spain, the United Kingdom/Northern Ireland, and the United States. They will be assigned to the BPD or comparison group retrospectively, based on their answers defining the BPD-status.

You may qualify if:

• BPD-group:
• Being a parent or primary caregiver of a child until the age of 18 years (0 to under 18 years),
• who was born preterm (before 37 weeks of gestation),
• who has been discharged from their initial hospital stay after birth,
• who suffered from BPD in the newborn period and
• who was born or is currently living in the following countries: France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland) and the United States
• providing sufficient proficiency in one of the languages of the questionnaire
• Control group:
• Being a parent or primary caregiver of a child until the age of 18 years (0 to under 18 years),
• who was born preterm (before 37 weeks of gestation),
• who has been discharged from their initial hospital stay after birth,
• who did not suffer from BPD in the newborn period and
• who was born or is currently living in the following countries: France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland) and the United States
• providing sufficient proficiency in one of the languages of the questionnaire

You may not qualify if:

• BPD-group:
• Other family members than parents/primary caregivers
• Parents or primary caregivers
• of a child older/equal than 18 years of age
• of a child with BPD who has not been discharged yet
• of a child without a BPD in the newborn period
• with insufficient proficiency in one of the languages available in the questionnaire
• Control group:
• Other family members than parents/primary caregivers
• Parents or primary caregivers
• of children older/equal than 18 years of age
• of a child born term
• of a child without BPD who has not been discharged yet
• with insufficient proficiency in one of the languages available in the questionnaire

Sponsors & Collaborators

• Global Foundation for the Care of Newborn Infants: lead
• European Society for Paediatric Research (ESPR): collaborator
• Union of European Neonatal and Perinatal Societies (UENPS): collaborator
• European Respiratory Society (ERS): collaborator

Study Sites (1)

Global Foundation for the Care of Newborn Infants (GFCNI)

München, Bavaria, 81379, Germany

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Caregiver Burden; Premature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stress, Psychological; Behavioral Symptoms; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Julia Feiler, Dr

  Global Foundation for the Care of Newborn Infants (GFCNI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Tischer, Dr

CONTACT

+49 (0)89 / 89083260; research@efcni.org

Julia Feiler, Dr

CONTACT

Julia.feiler@gfcni.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: September 16, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)