Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study

NCT06827028 | Not Yet Recruiting

• 1 other identifier: METC 2024-0411
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore parents' experiences and emotional burdens related to their newborn's hospital stay using an online survey. Our target population consists of parents of newborns born preterm, with low birthweight, or critically ill. Particularly the presence of infant- and family-centred developmental care (IFCDC) principles as well as support through political framework conditions will be investigated.

Conditions

Infant, Premature; Infant, Low Birth Weight; Parents; Life Change Events; Needs Assessment; Anxiety; Fear; Stress, Psychological; Uncertainty; Emotions; Caregiver Burden

Keywords

Parental needs; Infant- and Family-centred developmental care; IFCDC; EFCNI; NICU; Global Parent Survey; Breastfeeding; Breastfeeding support; Politics; Needs Assessment; HRQoL; Parents; Infant, Newborn; Family; Family Support; Family Health; Intensive Care, Neonatal; Patient-Centered Care; Infant Care; Surveys and Questionnaires; Health Care Surveys

Outcome Measures

Primary Outcomes (1)

• Infant Family-Centered Developmental Care principles

  The implementation of IFCDC principles will be measured as the percentage of infants receiving specific care, such as skin-to-skin contact, receiving breastfeeding support, access of parents/caregivers to the neonate, involvement in daily care procedures etc.

  01/09/2025 - 31/12/2027

Secondary Outcomes (5)

• Social/Financial/Political Support (Quantitative)

  01/09/2025 - 31/12/2027

• Social/Financial/Political Support (Qualitative)

  01/09/2025 - 31/12/2027

• Participant characteristics

  01/09/2025 - 31/12/2027

• Questionnaire pre-testing (quantitative)

  01/09/2025 - 31/12/2027

• Questionnaire pre-testing (qualitative)

  01/09/2025 - 31/12/2027

Other Outcomes (2)

• Single-Country evaluation of IFCDC implementation

  01/09/2025 - 31/12/2027

• Single-Country evaluation on the availability of supportive political measures

  01/09/2025 - 31/12/2027

Study Arms (1)

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.

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

Interventions

N/A, no intervention, participation in survey OTHER

N/A, no intervention, participation in survey

Parents/participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parent or caregiver of a newborn infant born on January 1, 2023, or thereafter, who received/is receiving special/intensive care starting within the first week of life such as oxygen therapy or other respiratory support, incubator treatment, intravenous infusions, treatment of (suspected) sepsis, pneumonia, necrotising enterocolitis, malformations, jaundice, nutritional/feeding problems, hypoglycemia, etc.

You may qualify if:

• Parent or caregiver of a newborn infant born on January 1, 2023, or thereafter, who received/is receiving special/intensive care starting within the first week of life such as oxygen therapy or other respiratory support, incubator treatment, intravenous infusions, treatment of (suspected) sepsis, pneumonia, necrotising enterocolitis, malformations, jaundice, nutritional/feeding problems, hypoglycemia, etc.

You may not qualify if:

• Other family members than parents/(primary) caregivers
• 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

Sponsors & Collaborators

• Global Foundation for the Care of Newborn Infants: lead

Study Sites (1)

Global Foundation for the Care of Newborn Infants (GFCNI)

Munich, Bavaria, 81379, Germany

Location

Related Publications (5)

• 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.

  PMID: 34401688 BACKGROUND

• 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.

  PMID: 35393317 BACKGROUND

• 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.

  PMID: 36717224 BACKGROUND

• 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.

  PMID: 28906423 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Premature Birth; Anxiety Disorders; Stress, Psychological; Caregiver Burden; Breast Feeding

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Feeding Behavior

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

• Silke Mader

  Global Foundation for the Care of Newborn Health (GFCNI)

  STUDY CHAIR

• Helmut Hummler, M.D., M.B.A.

  Global Foundation for the Care of Newborn Health (GFCNI)

  STUDY DIRECTOR

• Luc Zimmermann, Professor

  Global Foundation for the Care of Newborn Health (GFCNI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Hoffmann, Dr

CONTACT

+49 89 89 0 83 260; julia.hoffmann@gfcni.org

Christina Tischer, Dr

CONTACT

christina.tischer@gfcni.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: February 14, 2025
• Study Start: September 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

DE (1)