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

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          Abstract

          Introduction

          Preterm 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 analysis

          This 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 dissemination

          Ethical 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 number

          NCT02736136, Pre-results.

          Related collections

          Most cited references 81

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          Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale.

          The development of a 10-item self-report scale (EPDS) to screen for Postnatal Depression in the community is described. After extensive pilot interviews a validation study was carried out on 84 mothers using the Research Diagnostic Criteria for depressive illness obtained from Goldberg's Standardised Psychiatric Interview. The EPDS was found to have satisfactory sensitivity and specificity, and was also sensitive to change in the severity of depression over time. The scale can be completed in about 5 minutes and has a simple method of scoring. The use of the EPDS in the secondary prevention of Postnatal Depression is discussed.
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            Maternal psychological distress and parenting stress after the birth of a very low-birth-weight infant.

             Lynn Singer (1999)
            Few studies document how parents adapt to the experience of a very low-birth-weight (VLBW; 36 weeks, >2500 g). Standardized, normative self-report measures of maternal psychological distress, parenting stress, family impact, and life stressors. Mothers of VLBW infants (high risk, n = 122; low risk, n = 84) had more psychological distress than mothers of term infants (n=123) at 1 month (13% vs 1%; P = .003). At 2 years, mothers of low-risk VLBW infants did not differ from term mothers, while mothers of high-risk infants continued to report psychological distress. By 3 years, mothers of high-risk VLBW children did not differ from mothers of term children in distress symptoms, while parenting stress remained greater. Severity of maternal depression was related to lower child developmental outcomes in both VLBW groups. The impact of VLBW birth varies with child medical risk status, age, and developmental outcome. Follow-up programs should incorporate psychological screening and support services for mothers of VLBW infants in the immediate postnatal period, with monitoring of mothers of high-risk VLBW infants.
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              CRIB II: an update of the clinical risk index for babies score.

              The clinical risk index for babies (CRIB) score is a risk-adjustment instrument widely used in neonatal intensive care. Its appropriateness with contemporary data has been questioned. We have examined these questions, developed a new five-item CRIB II score with data from a UK-wide sample of infants admitted to neonatal intensive care in 1998-99, and shown how mortality after neonatal intensive care has fallen in the past 12 years. CRIB II provides a recalibrated and simplified scoring system that avoids the potential problems of early treatment bias. A valid and simple method of risk-adjustment for neonatal intensive care is important to ensure accurate assessment of quality of care. Such assessments should be done in tandem with national audit systems for neonatal intensive care, incorporating measures of morbidity as well as mortality.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                30 March 2019
                : 9
                : 3
                Affiliations
                [1 ] departmentWoman-Mother-Child, Clinic of Neonatology , Centre Hospitalier Universitaire Vaudois , Lausanne, Switzerland
                [2 ] departmentChild and Adolescent Psychiatry , Centre Hospitalier Universitaire Vaudois , Lausanne, Switzerland
                [3 ] departmentPsychomotricity Institute , University of Applied Sciences and Arts Western Switzerland , Geneva, Switzerland
                [4 ] departmentInstitute of Higher Education and Research in Healthcare , University of Lausanne , Lausanne, Switzerland
                [5 ] departmentWoman-Mother-Child, Clinic of Neonatology , Lausanne University Hospital , Lausanne, Switzerland
                Author notes
                [Correspondence to ] Professor Antje Horsch; antje.horsch@ 123456chuv.ch
                Article
                bmjopen-2018-026484
                10.1136/bmjopen-2018-026484
                6475149
                30928952
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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                Categories
                Paediatrics
                Protocol
                1506
                1719
                Custom metadata
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                Medicine

                preterm, early intervention, developmental care, self-efficacy, parenting, mother

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