Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care

Abstract

IntroductionPreterm birth may generate significant distress among the parents, who often present with difficulties in appropriating their parental role. Parental stress and low perceived parental self-efficacy may interfere with the infant’s socioemotional and cognitive development, particularly through disrupted parent–infant interactions. Perceived parental self-efficacy represents the belief of efficacy in caring for one’s own infant and successful incarnation of the parental role, as well as the perception of one’s own abilities to complete a specified task. Interventions to support parental role, as well as infant development, are needed, and parental self-efficacy represents a useful indicator to measure the effects of such early interventions.Methods and analysisThis study protocol describes a randomised controlled trial that will test an early intervention in the neonatal intensive care unit (NICU) (JOIN: Joint Observation In Neonatology) carried out by an interdisciplinary staff team. Mothers of preterm neonates born between 28 and 32 6/7 weeks of gestational age are eligible for the study. The intervention consists of a videotaped observation by a clinical child psychologist or child psychiatrist and a study nurse of a period of care delivered to the neonate by the mother and a NICU nurse. The care procedure is followed by an interactive video guidance intended to demonstrate the neonate’s abilities and resources to his parents. The primary outcome will be the difference in the perceived maternal self-efficacy between the intervention and control groups assessed by self-report questionnaires. Secondary outcomes will be maternal mental health, the perception of the parent– infant relationship, maternal responsiveness and the neurodevelopment of the infant at 6 months corrected age.Ethics and disseminationEthical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 496/12). Results from this study will be disseminated at national and international conferences, and in peer-reviewed journals.Trial registration numberNCT02736136, Pre-results.

Emotional responses of parents participating for the first time in caregiving for their baby in a neonatal unit

“…Parents of term infants who expressed feelings of stress or fear revealed that it was frequently because of the highly technical environment surrounding their baby. Those negative feelings are known to be associated with increased difficulty in building a positive parent‐infant relationship 41,42 . We highlighted that it is important for parents to do something positive for their baby: they want to touch, help and support their baby 7 .…”

The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial

“…The study protocol, which the ethical committee of the canton of Vaud approved, was previously published [ 12 ]. The specific methods relative to the secondary outcome examined in the present study are summarised hereafter.…”

“…Based on previous research, the interactive guidance through video feedback increases parental sensitivity, while decreasing the stress generated by the NICU stay, and has positive effects on the quality of the mother–infant interaction [ 18 ]. For more details, see [ 12 ].…”

“…We conducted a randomised controlled trial examining the effects of an early intervention, the Joint Observation in the NICU (JOIN), delivered in the NICU with the mother and her preterm neonate. Using video feedback, competences of the preterm neonate and reciprocal interactions were demonstrated to the mother [ 12 ]. The primary outcome of this study was the difference in maternal perceived self-efficacy between the two groups.…”

“…The main objective of the present work was to measure the impact of the JOIN intervention on the neurodevelopment of the preterm infant at six months corrected age (CA) in the intervention group compared to the control group. We hypothesised that by reinforcing the perception of parental efficacy, the JOIN intervention would allow for better stimulation of the infants and positively impact their neurodevelopment as measured by a standardised assessment at six months CA [ 12 ].…”