Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study
NCT ID: NCT06827028
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-09-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study
NCT01974531
Analysis of Mother-child Interaction and Regulation of Candidate Genes of Stress Signaling Pathways in Mature Infants
NCT03926923
Neonatal Pain- and Distress Experiences and Later Pain Behavior of Former Preterm and Critically Ill Newborn Infants
NCT00926445
Study of the Prevalence of Complications Occurring in the Mother-newborn Couple During the First Month After Returning Home, Since the Introduction of Standard Outpatients (According to HAS 2014 Recommendations) at the Amiens-Picardie University Hospital
NCT03114930
The Contribution of Internal Maternal Resources to Creation of Motherhood. Comparison Among Mothers to Twins and Singleton
NCT00353236
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The CWG, with n=27 members, and a Support Group (SG), with n=48 members, both consisting of individual multi-professional experts from all continents working in the field of maternal and newborn health, will be assembled. Both groups support the development of the questionnaire in a two-step approach, translations of the questionnaire, the recruitment of participants, data analysis, data interpretation, and publication and dissemination of results. While the CWG, will be actively involved in the initial development of the draft questionnaire, the SG will be involved for a broader review for the revision and final correction of the questionnaire in a second step.
Development of the Questionnaire For the purpose of the HOPE study, we performed a scoping review (1) to explore the available literature related to this topic and to identify the most relevant topics to be included in the questionnaire.
After this literature research, the questionnaire was drafted considering the already existing and validated EMPATHIC-N and the PICKER questionnaires (2,3), as well as the questionnaire, we previously developed to explore parents' experiences related to challenges during the COVID-19 pandemic regarding the care of their newborns (4,5). In addition, questions related to political, social and infrastructural framework conditions were included.
The online questionnaire includes single, multiple choice answer models and some open-text fields. Besides questions related to participant characteristics such as age, sex, country of location, infant birthweight, duration of hospitalisation, etc., the questionnaire includes questions related to the parents' perception of political, social and infrastructural framework conditions as experienced within their country as well as elements of neonatal care mainly involving aspects of IFCDC such as the use and support of breast/human milk and early breast feeding, skin-to-skin care (kangaroo-mother care), parental presence and involvement in the care, shared decision making, stress and pain control etc. during their hospital stay.
In order to maximise the reach and to prevent the loss of study participants due to time constraints, a multi-stage approach will be used, beginning with 47 high-priority questions (single and multiple answer options), followed by more specific second lower-priority questions (single and multiple answer options) (n=21). This first/second layer approach aims to increase the response rate for the most important questions and to keep the effort for participants with limited time resources to a minimum, while taking advantage of the motivation of participants who are willing to share the full scope of their experiences related to their baby's hospitalisation.
The questionnaire draft will be reviewed by the CGW and after having implemented necessary changes, the updated version will be shared with the larger SG for feedback and review. Both groups will ensure that the questionnaire considers the specific national perspective and that the questions are phrased. All implemented changes and the finally updated version of the questionnaire will be discussed with both groups including the representative from the collaboration partners in digital discussion meetings.
In addition, comprehensive interviews with up to 10 participants resembling the target group will be performed to elucidate other relevant topics that may have not yet been covered and need to be included.
The first questionnaire draft (in English) with included feedback from the interviews and experts and will be pre-tested by a comparable target group to receive qualitative feedback on the questionnaire per se and the phrasing.
After a potential adaptation based on data and information of the pre-testing, the questionnaire will be translated in as many different languages as feasible to overcome the linguistic barrier and facilitate participation for parents worldwide. The CWG and SG will support and review the translations. The translated questionnaire versions will be transferred into the online survey software SurveyMonkey ® and will be distributed via the expert groups, GFCNI's network, GFCNI's newsletter and social media channels via an access link.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Parents/participants
Study participants are parents of newborns that are receiving or received special/intensive care starting within the first week of life and that are born on 1 January 2023 or thereafter. The cohort consists of persons with different ethnic background in different countries that voluntarily participate in the survey.
N/A, no intervention, participation in survey
N/A, no intervention, participation in survey
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
N/A, no intervention, participation in survey
N/A, no intervention, participation in survey
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Parents of newborns that did not receive special/intensive care starting within the first week of life
* Parents or caregivers of infants born before 1 January 2023
* Persons with insufficient proficiency of one of the languages of the questionnaire
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Global Foundation for the Care of Newborn Infants
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luc Zimmermann
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Silke Mader
Role: STUDY_CHAIR
Global Foundation for the Care of Newborn Health (GFCNI)
Helmut Hummler, M.D., M.B.A.
Role: STUDY_DIRECTOR
Global Foundation for the Care of Newborn Health (GFCNI)
Luc Zimmermann, Professor
Role: PRINCIPAL_INVESTIGATOR
Global Foundation for the Care of Newborn Health (GFCNI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Global Foundation for the Care of Newborn Infants (GFCNI)
Munich, Bavaria, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Kostenzer J, Hoffmann J, von Rosenstiel-Pulver C, Walsh A, Zimmermann LJI, Mader S; COVID-19 Zero Separation Collaborative Group. Neonatal care during the COVID-19 pandemic - a global survey of parents' experiences regarding infant and family-centred developmental care. EClinicalMedicine. 2021 Aug 6;39:101056. doi: 10.1016/j.eclinm.2021.101056. eCollection 2021 Sep.
Kostenzer J, von Rosenstiel-Pulver C, Hoffmann J, Walsh A, Mader S, Zimmermann LJI; COVID-19 Zero Separation Collaborative Group. Parents' experiences regarding neonatal care during the COVID-19 pandemic: country-specific findings of a multinational survey. BMJ Open. 2022 Apr 7;12(4):e056856. doi: 10.1136/bmjopen-2021-056856.
Sakonidou S, Kotzamanis S, Tallett A, Poots AJ, Modi N, Bell D, Gale C. Parents' Experiences of Communication in Neonatal Care (PEC): a neonatal survey refined for real-time parent feedback. Arch Dis Child Fetal Neonatal Ed. 2023 Jul;108(4):416-420. doi: 10.1136/archdischild-2022-324548. Epub 2023 Jan 30.
Gill FJ, Wilson S, Aydon L, Leslie GD, Latour JM. Empowering Parents of Australian Infants and Children in Hospital: Translation, Cultural Adaptation, and Validation of the EMpowerment of PArents in The Intensive Care-30-AUS Questionnaire. Pediatr Crit Care Med. 2017 Nov;18(11):e506-e513. doi: 10.1097/PCC.0000000000001309.
Family-centered care in the NICU in a global setting : Ayse Duezenli : Free Download, Borrow, and Streaming. Available from: https://archive.org/details/osf-registrations-erqf7-v1
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
METC 2024-0411
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.