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fAMily Integrated CAre in the neonatal ward - the AMICA-study

fAMily Integrated CAre in the neonatal ward - the AMICA-study - the AMICA-study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47775
Enrollment
1953
Registered
2016-12-22
Start date
2017-05-17
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Prematurity

Interventions

None listed

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Born between 24 and 37 weeks of gestational age - At least 1 week of hospitalisation - Will not be transferred to an other hospital before discharge - Will visit the Outpatient Clinic of the OLVG East, OLVG West and NWZA (location Alkmaar) after discharge

Exclusion criteria

Exclusion criteria: - Metabolic or chromosomal/syndromal diseases - Therapeutic hypothermia for perinatal asphyxia - Severe psychiatric or psychosocial problems i.e. parents under supervision of youth care - Transfer to another hospital before discharge - Parents are unable to answer the questionnaires in Dutch/English - Death of an infant or life-threatening illness of sibling

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of Family Integrated Care in SFR on neurodevelopmental outcome at 2 years of (corrected) age in newborns hospitalized in a level-2 Neonatal Ward for at least 1 week as compared to standard neonatal care in open bay units as measured by the Ages and Stages Questionnaire 3rd edition. To evaluate the effect of Family Integrated Care in SFR on parental stress at discharge as compared to standard neonatal care in open bay units as measured by the Parental Stress Scale. To study and provide norms of parental (traumatic) stress, parent-infant bonding, depression and anxiety and parental self-efficacy over time in the healthy (non-hospitalised) population.

Secondary

MeasureTime frame
To study short-term clinical outcomes of Family Integrated Care in SFR in newborns hospitalized to a level-2 Neonatal Ward for at least 1 week (e.g. breastfeeding rates, growth, sepsis, respiratory support, critical incidents, duration of hospital stay). Infants will be followed-up after discharge until the age of 2 years to assess breastfeeding rates, growth, iron status, hospital readmission and psychomotor development. To study the influence of at least 1 week Family Integrated Care in SFR on parental outcome measures like parent-infant bonding, degree of family centred care, parental self-efficacy, parental satisfaction levels during hospital stay and after discharge. To study the effect of Family Integrated care in SFR on longterm cortisol levels in hair (in infants and in parents).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)