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Health related Quality of Life in Parents of hospitalized Neonates

Health related Quality of Life in Parents of hospitalized Neonates

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00020468
Enrollment
150
Registered
2020-01-13
Start date
2020-01-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life stress

Interventions

Group 1: Parents of premature and/or sick newborns in the neonatal intensive care unit Assessment of the quality of life of the parents 14 days, 6, 12 and 24 months postpartum PARCA-R's parental asse
24 months postnatal
additionally for healthy newborns: developmental neurological examination (Bayley III) Baseline 14 days, 6, 12, 24 months postnatal: age, gender, education and relationship status of the parents as we

Sponsors

Universitätsmedizin Mainz, Abteilung Neonatologie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cohort of premature babies: stay on NICU = 14 days Cohort of the term infants: stay at the weekly ward = 24 hours

Exclusion criteria

Exclusion criteria: Lack of knowledge of German; basic mental illness of parents; Transfer of the child; Death of the child; Multiple births; Children in the control group who are treated in hospital 28 days before their life

Design outcomes

Primary

MeasureTime frame
Parental quality of life Hypothesis: The health-related quality of life of parents of newborns who received inpatient medical treatment for 14 days or longer is 6 months after birth lower than that of parents whose children were discharged from the maternity hospital after 1 to 3 days of life without medical treatment. Health-related quality of life is recorded using the Pediatric Quality of Life InventoryTM (PedsQLTM) questionnaire (Family Impact Module), which is divided into 8 areas. These include physical, emotional, social, cognitive, communicative, fear-related, family and job-related aspects. The Family Impact Module is an extension of the PedsQLTM questionnaire by Varni et al. (1998). For application in the German-speaking world, Felder-Puig et al. 2003 the validation of the German-language PedsQLTM related to cancer and epilepsy by (Felder-Puig et al., 2004). There is an official German version of the questionnaire and associated module on family impact. Assessment 14 days, 6,12,24 months after birth

Secondary

MeasureTime frame
1. The stress level of parents of newborns who received inpatient medical treatment for 14 days or longer 2. Satisfaction with medical treatment (when discharged after inpatient treatment) 3. Development / tendency of the quality of life 4. Assessment of parental competence 5. Social / family situation 6. Financial and occupational burden as well as gender differences 7. The development of newborns who received inpatient medical treatment for 14 days or longer compared to healthy newborns to 1. Score in the PSS: NICU_German / 2-scales questionnaire after 14 (10-21) days postpartum 2. Questionnaire on satisfaction with medical treatment (on discharge) 3. Parental quality of life: PedsQLTM (module family impact) after 14 (10-21) days and 6 (5-7), 12 (10-14), 24 (20-28) months postpartum 4. Subjective assessment of parental competence: PSOC questionnaire after 6 (5-7), 12 (10-14), 24 (20-28) months postpartum 5.Baseline questionnaire on social and professional situation 14 (10-21) days and 6 (5-7), 12 (10-14), 24 (20-28) months postpartum 6. See 5. 7. Developmental neurological status 24 (20-28) months postnatally (Bayley III and PARCA-R) for in-patient children and PARCA-R for non-in-patient children

Countries

Germany

Contacts

Public ContactMascha Schönfeld

Universitätsmedizin Mainz, Abteilung Neonatologie

Mascha.schoenfeld@unimedizin-mainz.de00496131175892

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026