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

Due to the technological environment of the modern neonatal ward, premature or
sick newborns and their parents are commonly separated worldwide, and both
physical and emotional closeness is impaired. The early postnatal life is a
sensitive period of development and impairment of mother- infant interactions
(such as maternal separation or deprivation) is a threat to this.
Developmental research has firmly established the quality of the
relationship between an infant and his or her parent as an important factor
influencing the child*s later development. When children develop a secure
relationship with their parents or caregivers in their first years of life,
they generally have better cognitive outcomes, better social interactions,
display less behavioural problems, and achieve better at school.
Parents of ill newborns experience high levels of stress, anxiety and
depression. This is of concern since the mental and psychological health of the
mother can affect her relationship with her infant and thus the infant*s
cognitive and emotional development.
To address the well-known disadvantages of early separation, we have adapted
and implemented a Family Integrated Care model for use in a level 2 Neonatal
Ward with Single Family Rooms (SFRs) in which parents provide most of the care
for their infant, while nurses support, teach and counsel parents.

Our primary objectives are:
1. 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.
2. 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.
3. 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.

In this prospective observational cohort study we will study infants and
parents cared for with Family Integrated Care in Single Family Rooms for at
least 1 week compared to infants and parents who were provided with standard
neonatal care in open bay units in 2 other hospitals.

Due to the nature of this study, and hospital architectural design,
randomisation between hospitals is not possible. Also randomisation within
hospitals is not possible, with the possible effect of cross-contamination.
Therefore, we have chosen for a prospective observational cohort study with 1
intervention centre, 2 standard care centres and a random selection of control
infants visiting the infant health care centres within the area of the
hospitals.
Group A (intervention) is treated with Family Integrated Care in SFR and group
B (standard care) treated with standard neonatal care in OBU. In OLVG East
infants will enter Group A, in OLVG West and NWZA infants will enter Group B.
All wards are level 2 Neonatal Wards, with a comparable patient population (see
further section 5: table 1). Longitudinally, a communal random sample of
infants and their parents at the infant health care centers (GGD) around the
participating hospitals will be followed to control for and cross-validate
outcomes. The study will not be blinded.

Up till now, no study has been performed regarding involvement of parents in
care for infants from 30 weeks of postnatal age in a Level 2 Neonatal Ward. If
we are able to show that this new concept of care in these groups of vulnerable
patients is better than standard care regarding neurodevelopment and parental
stress, this concept of care should be considered as a strategy in other
neonatal wards.

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 2 times 20-30 minutes during hospital stay and at
discharge. And during follow-up parents will be asked to fill out
questionnaires 4 times befeore their visit at the outpatient clinic. The burden
for the newborns is none since all studied parameters are part of the routine
clinical care and are noted in the clinical chart.
Scoring the forms on stress, anxiety, self-efficacy and bonding leaves us with
a signaling attitude towards the parents* (mental) health. Parents are usually
supported by a child-psychologist during stay in the ward. If the
questionnaires are indicative of the necessity of (psychological) help for the
parents, than we will notify the parents and will search for appropriate
assistance (ie notify the treating doctor or general practitioner in
consultation with the parents).

Additionally, the collection of hair samples is done on the posterior vertex of
the head. Approximately 100 hairs will be sampled.