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Bronchopulmonary Dysplasia (BPD)BronQ FamilyNCT07134387

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

An observational study of Bronchopulmonary Dysplasia (BPD) and Chronic Lung Disease of Newborn, run by Global Foundation for the Care of Newborn Infants at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 18 yearsHealthy volunteers can take part
How many people
480 participants
Where
1 siteGermany
Study dates
16 Sep 2025to Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christina Tischer, Dr contact

+49 (0)89 / 89083260

research@efcni.org

Julia Feiler, Dr contact

Julia.feiler@gfcni.org

Germany1 site, 1 recruiting
  • Global Foundation for the Care of Newborn Infants (GFCNI)

    München, Bavaria, 81379

    Christina Tischer, Dr, +49 (0)89 / 89083260, christina.tischer@gfcni.org

    Recruiting

Other trials in Germany

About this study

Official title: BronQ Family: Assessing the Long-term Impact of Bronchopulmonary Dysplasia (BPD) on Affected Families' Health-related Quality of Life

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.

Read the detailed description

The study will be designed as an observational, cross-sectional survey with a comparison group using a self-administered, web-based questionnaire for retrospective data collection. The study will use a multi-lingual online survey collecting data from parents in France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland), and the United States. Following a participatory research approach, the study will be carried out in close collaboration with representatives of national and international parent organizations, affected parents and/or former patients, professional healthcare societies, healthcare professionals as well as health researchers in the form of a Project Expert Group (PEG). It includes medical experts in BPD and neonatal/pediatric care, parent representatives, and, if applicable, parents of children affected by BPD during the neonatal period and/or affected patients from the countries of interest. The PEG will be complemented by the External Scientific Advisory Board (ESAB), which comprises n=4 members, including researchers specializing in HRQoL and/or pediatric respiratory outcomes research, including BPD. The PEG and ESAB will be engaged in all stages of the research project through regular online meetings. The ESAB contributes mainly to the study design and conception, questionnaire development, data analysis and interpretation, and will support the development of scientific publications. The remaining members of the PEG are involved in reviewing all final materials generated from the project and support the recruitment of study participants, as well as the dissemination of findings within their professional networks.

After comprehensive literature research and exchange with the study experts, the questionnaire will be drafted considering the already existing PedsQL Family Impact Module (FIM) (15) to assess parental HRQoL. In addition to socio-demographic information and inclusion/exclusion criteria, the questionnaire includes items evaluating various dimensions of parental HRQoL, health literacy and support structures. Furthermore, questions assessing the child's medical situation, treatment and eventual co-morbidities during the newborn period as well as at the time of the current survey will be added. Ultimately, questions addressing the financial burden of medical costs will be considered to assess the personal impact as well as the impact on the healthcare system in the respective countries. 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.

The questionnaire draft will be developed in close collaboration with the ESAB and reviewed by the PEG. After implementing necessary changes, the updated version will be shared again with the expert groups for final review. In addition, a pretest with up to 10 participants resembling the target group will be performed to elaborate on understanding, relevance and completeness as well as to elucidate other relevant topics that have not yet been covered and still need to be included.

After a potential adaptation based on data and information of the pre-testing, the questionnaire will be translated in the respective country languages with the PEG reviewing the translations. The translated questionnaire versions will be transferred into the online survey software SurveyMonkey® and will be distributed via the PEG/ESAB, GFCNI's network, GFCNI's newsletter and social media channels via an access link.

GFCNI received a research grant from Chiesi in support of this independent study.

Being tested
N/A, no intervention, participation in survey
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
Medical subject headings
Bronchopulmonary Dysplasia, Caregiver Burden, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N/A, no intervention, participation in surveyOther

    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.

Study groups in NCT07134387
Study groupRoleWhat they receive
Parents or caregivers of children with (a history of) physician diagnosed BPDThe 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.
Receives: Other: N/A, no intervention, participation in survey
Parents or caregivers of preterm born children without chronic health conditionsThe 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.
Receives: Other: N/A, no intervention, participation in survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 09/2025 - 02/2026

Secondary outcomes (5)
  1. Participant characteristics assesed by self developed online questionnaire

    Inclusion/exclusion criteria, Baseline characteristics, socio-demographic characteristics of parent/caregiver, child, and the family situation

    Measured: 09/2025 - 02/2026

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

    The section assesses the child's overall health, daily functioning, school attendance, and involvement of medical specialists. It covers emotional, cognitive, and behavioral issues (potentially linked to BPD), respiratory health (symptoms, infections, treatments, support), and feeding difficulties. It also records comorbidities and developmental impairments, and includes questions on RSV prevention and infection history.

    Measured: 09/2025 - 02/2026

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

    The Family Finances section captures family costs related to caring for a child with health conditions, including direct and broader economic impacts such as financial burden, work productivity loss, and healthcare utilization.

    Measured: 09/2025 - 02/2026

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

    Disease awareness and awareness of consequences

    Measured: 09/2025 - 02/2026

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

    Measured: 09/2025 - 02/2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start16 Sep 2025
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134387
Sponsor's protocol ID
METC 2025-0285
Acronym
BronQ Family
Status last verified
Nov 2025
First submitted
14 Aug 2025
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Trautmannsberger I, Wydrin V, Duzenli A, Breunig L, Mader S, Tischer C, Feiler J. BronQ Family: assessing the long-term impact of Bronchopulmonary Dysplasia on affected families' health-related quality of life - protocol of a multi-country study. BMJ Paediatr Open. 2026 Apr 30;10(1):e004252. doi: 10.1136/bmjpo-2025-004252.

    PubMed 42062067

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchopulmonary Dysplasia (BPD) and Chronic Lung Disease of Newborn, run by Global Foundation for the Care of Newborn Infants at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christina Tischer, Dr (+49 (0)89 / 89083260, research@efcni.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parental health-related quality of life (HRQoL) assesed by Pediatric Quality of Life Inventory, Family Impact Module (PedsQL FIM) (time frame: 09/2025 - 02/2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07134387, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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