fAMily Integrated CAre in the neonatal ward - the AMICA-study
Completed
- Conditions
- 10016214Prematurity1002892010001302
- Registration Number
- NL-OMON47775
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1953
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
- 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effect of Family Integrated Care in SFR on neurodevelopmental<br /><br>outcome at 2 years of (corrected) age in newborns hospitalized in a level-2<br /><br>Neonatal Ward for at least 1 week as compared to standard neonatal care in open<br /><br>bay units as measured by the Ages and Stages Questionnaire 3rd edition.<br /><br>To evaluate the effect of Family Integrated Care in SFR on parental stress at<br /><br>discharge as compared to standard neonatal care in open bay units as measured<br /><br>by the Parental Stress Scale.<br /><br>To study and provide norms of parental (traumatic) stress, parent-infant<br /><br>bonding, depression and anxiety and parental self-efficacy over time in the<br /><br>healthy (non-hospitalised) population. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To study short-term clinical outcomes of Family Integrated Care in SFR in<br /><br>newborns hospitalized to a level-2 Neonatal Ward for at least 1 week (e.g.<br /><br>breastfeeding rates, growth, sepsis, respiratory support, critical incidents,<br /><br>duration of hospital stay).<br /><br>Infants will be followed-up after discharge until the age of 2 years to assess<br /><br>breastfeeding rates, growth, iron status, hospital readmission and psychomotor<br /><br>development.<br /><br>To study the influence of at least 1 week Family Integrated Care in SFR on<br /><br>parental outcome measures like parent-infant bonding, degree of family centred<br /><br>care, parental self-efficacy, parental satisfaction levels during hospital stay<br /><br>and after discharge.<br /><br>To study the effect of Family Integrated care in SFR on longterm cortisol<br /><br>levels in hair (in infants and in parents). </p><br>