To evaluate the effect of FICare in SFR on cognitive development at 5.5 years of age as measured by the WPPSI-IV in preterm infants hospitalised in a level-2 Neonatal Ward as compared to SNC in OBU To evaluate the effect of FICare in SFR on parental…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Anxiety disorders and symptoms
- Family issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome for the children is cognitive development at 5.5 years of
age as defined by the total score on the Wechsler Preschool and Primary Scale
of Intelligence-Fourth Edition (WPPSI-IV). The WPPSI-IV is an intelligence test
designed for children aged 2 years 6 months to 7 years 7 months, performed by
trained and certified psychologists.
The primary outcome for the parents is parenting stress defined by the total
score on the Parenting Stress Questionnaire (PSQ). The PSQ is a 34-items
self-report measure that assesses among other things parental stress and
parent-child bonding.
Secondary outcome
Secondary outcome measures on the children are additional developmental
outcomes behaviour (assessed with the CBCL), speech (assessed with VAI),
social-emotional development (assessed with ASQ-SE)); growth
(length/weight/BMI); and health-related quality of life (assessed with the
PedsQL) at 5.5 years of age.
Secondary outcomes for the parents are additional mental health outcomes as
measured by depression and anxiety (assessed with PROMIS-AD); distress
(assessed with DT-P); and posttraumatic stress (assessed with PCL-5) at 5.5
years of age.
Background summary
Parents are often appointed a passive role during the admission of their
preterm or ill newborn. Multiple studies have demonstrated that information,
communication and participation are crucial for families of intensive care
patients.
However, common practice in neonatal wards regarding daily rounds is that the
medical rounds are only attended by the physician and nurse without the
presence and participation of the parents. Family Integrated Care (FICare)
consists of bringing parents, medical and nursing staff together and involving
parents as equal partners, minimizing separation, and supporting parent-infant
closeness. FICare has a collaborative program of psychological, educational,
communication, and environmental strategies to support parents to cope with the
neonatal environment and to prepare them to be able to emotionally,
cognitively, and physically care for their infant. In this study we want to
study the effect on the long term effects of FICare.
Study objective
To evaluate the effect of FICare in SFR on cognitive development at 5.5 years
of age as measured by the WPPSI-IV in preterm infants hospitalised in a level-2
Neonatal Ward as compared to SNC in OBU
To evaluate the effect of FICare in SFR on parental mental health outcome at
5.5 years in parents of newborns hospitalized in a level-2 Neonatal Ward as
compared to SNC in OBU as measured by parenting stress questionnaire (PSQ).
Study design
This is a follow up study of the AMICA study (NL Trial Register 6175). The
original AMICA study was a prospective observational cohort study with 1 FICare
centre, 2 standard care centres designed to study the effect of the FICare
setting compared to a standard care setting on infant and parent outcomes up to
2 years of age corrected for prematurity.
Intervention
n.a.
Study burden and risks
The only burden for the parents is time-related, for filling out the
questionnaires. The total amount of time required to fill out the
questionnaires will be 60 minutes. The burden for the child's concerns the
WPPSI-IV, which will take approximately 30-45 minutes. This intelligence test
is scored by trained and certified psychologists. As the test is non-invasive,
relatively short and is generally experienced as a fun test for children, the
burden is deemed to be minimal. Scoring the forms on stress, anxiety,
depression and parenting stress leaves us with a signalling attitude towards
the parents* (mental) health. If the questionnaires are indicative of the
necessity of (psychological) help for the parents, then we will notify the
parents and will search for appropriate assistance (i.e. notify the treating
doctor or general practitioner in consultation with the parents).
In the children cared for according to the FICare concept (group A) a benefit
could be that by involvement of parents during their neonatal hospitalisation
after birth, the neurodevelopment in these children is improved.
If we are able to show that this new concept of care in this group of
vulnerable patients is better than standard care regarding neurodevelopment of
the child and parental stress in the long term, this concept of care should be
considered as a strategy in other neonatal wards too. No study has been
performed regarding involvement of parents in care and cure for infants from 30
weeks of postnatal age. Thereby, no study was carried out to measure the long
term effects of FICare on growth and neurodevelopmental outcome. This could
lead to introduction of FICare as the golden standard of neonatal care in all
neonatal wards and thereby decreasing morbidities in this group of preterm
infants.
Concluding, the risks are negligible, the burden is minimal and this study
might show equal or better outcomes in children treated with FICare. This
implies that the research-question is group-related and can only be performed
in this group of children.
Oosterpark 9
Amsterdam 1092AE
NL
Oosterpark 9
Amsterdam 1092AE
NL
Listed location countries
Age
Inclusion criteria
Written informed consent to approach for follow-up study of the AMICA study.
Exclusion criteria
No consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81577.100.22 |