key: cord-1010042-9csr8p5r authors: van Veenendaal, Nicole R.; van Kempen, Anne A. M. W.; Broekman, Birit F. P.; de Groof, Femke; van Laerhoven, Henriette; van den Heuvel, Maartje E. N.; Rijnhart, Judith J. M.; van Goudoever, Johannes B.; van der Schoor, Sophie R. D. title: Association of a Zero-Separation Neonatal Care Model With Stress in Mothers of Preterm Infants date: 2022-03-28 journal: JAMA Netw Open DOI: 10.1001/jamanetworkopen.2022.4514 sha: 15cfb2af05fd4895c06f048eddd43ec9d1de9f8f doc_id: 1010042 cord_uid: 9csr8p5r IMPORTANCE: Active participation in care by parents and zero separation between parents and their newborns is highly recommended during infant hospitalization in the neonatal intensive care unit (NICU). OBJECTIVE: To study the association of a family integrated care (FICare) model with maternal mental health at hospital discharge of their preterm newborn compared with standard neonatal care (SNC). DESIGN, SETTING, AND PARTICIPANTS: This prospective, multicenter cohort study included mothers with infants born preterm treated in level-2 neonatal units in the Netherlands (1 unit with single family rooms [the FICare model] and 2 control sites with standard care in open bay units) between May 2017 and January 2020 as part of the AMICA study (fAMily Integrated CAre in the neonatal ward). Participants included mothers of preterm newborns admitted to participating units. Data analysis was performed from January to April 2021. EXPOSURES: FICare model in single family rooms with complete couplet-care for the mother-newborn dyad during maternity and/or neonatal care. MAIN OUTCOMES AND MEASURES: Maternal mental health, measured using the Parental Stress Scale: NICU (PSS-NICU). Secondary outcomes included survey scores on the Hospital Anxiety and Depression Scale, Postpartum Bonding Questionnaire, Perceived Maternal Parenting Self-efficacy Scale, and satisfaction with care (using EMPATHIC-N). Parent participation (using the CO-PARTNER tool) was assessed as a potential mediator of the association of the FICare model on outcomes with mediation analyses. RESULTS: A total of 296 mothers were included; 124 of 141 mothers (87.9%) in the FICare model and 115 of 155 (74.2%) mothers in SNC responded to questionnaires (mean [SD] age: FICare, 33.3 [4.0] years; SNC, 33.3 [4.1] years). Mothers in the FICare model had lower total PSS-NICU stress scores at discharge (adjusted mean difference, −12.24; 95% CI, −18.44 to −6.04) than mothers in SNC, and specifically had lower scores for mother-newborn separation (adjusted mean difference, −1.273; 95% CI, −1.835 to −0.712). Mothers in the FICare model were present more (>8 hours per day: 105 of 125 [84.0%] mothers vs 42 of 115 [36.5%]; adjusted odds ratio, 19.35; 95% CI, 8.13 to 46.08) and participated more in neonatal care (mean [SD] score: 46.7 [6.9] vs 40.8 [6.7]; adjusted mean difference, 5.618; 95% CI, 3.705 to 7.532). Active parent participation was a significant mediator of the association between the FICare model and less maternal depression and anxiety (adjusted indirect effect, −0.133; 95% CI, −0.226 to −0.055), higher maternal self-efficacy (adjusted indirect effect, 1.855; 95% CI, 0.693 to 3.348), and better mother-newborn bonding (adjusted indirect effect, −0.169; 95% CI, −0.292 to −0.068). CONCLUSIONS AND RELEVANCE: The FICare model in our study was associated with less maternal stress at discharge; mothers were more present and participated more in the care for their newborn than in SNC, which was associated with improved maternal mental health outcomes. Future intervention strategies should aim at reducing mother-newborn separation and intensifying active parent participation in neonatal care. TRIAL REGISTRATION: Netherlands Trial Register identifier NL6175 The AMICA study The AMICA study is a multicentre prospective observational cohort study on the association between an innovative FICare model in infants and their parents in a NICU level 2 context in the Netherlands. In this study a group of parents and infants who experienced family integrated care (FICare) in single family room units with complete couplet care for the mother-infant dyad, and a group who experienced standard care in open bay units are compared (the AMICA study 1 , see eFigure 1a-d). In the AMICA study, preterm infants admitted for at least 7 days to one of the participating wards and their parents were included. The primary outcome in the AMICA study is the association between the FICare model and neurodevelopment of preterm infants. In the AMICA study, outcomes in parents (mothers and fathers separately) were also included as secondary outcomes in the short and longer term. We excluded families if mothers or fathers had severe psychosocial problems (for instance acute psychiatric illness or if a family was under supervision ofsocial services etc.), if death of a sibling occurred or if a congenital or metabolic syndrome was present in the infant. Altered after van Veenendaal et al. 2 . In the Netherlands 17% of infants is born by cesarean section (8,1% primary and 7.9% secondary cesarean section) and approximately 70% of births occur in hospital (vs 30% in the community). In the Netherlands, 6.9% of infants are born preterm, and in the hospital region of Amsterdam the perinatal mortality rate (from 22 weeks of gestation up to 28 days after birth) is 0.56% (0.69% in the Netherlands) 3 . Different populations of preterm infants are defined within neonatal care in the Netherlands; Intensive care patients (IC), post-intensive high care patients, high-care (HC) patients and mediumcare (MC) patients. Intensive care infants: Infants who need intensive care (e.g. cardiorespiratory support) are referred to a level 3 neonatal intensive care unit (NICU). In 2010, the Dutch guideline on perinatal practice in extremely premature delivery lowered the limit offering intensive care from 25+0 to 24+0 weeks of gestational age 4 . Post-Intensive High Care infants: Infants who are expected to need intensive care (gestational age <32 weeks and/or expected birth weight <1200 gram) are born in one of the ten level 3 NICUs. Once these preterm infants are stable and their actual weight is (around) 1000 gram or more, they are transferred to a hospital with a Post-Intensive-Care unit (level-2 Neonatal Ward). These Post-Intensive High Care infants often are still on non-invasive respiratory support, and/or have central venous catheters for parenteral nutrition or receive multiple medications. High care infants: Infants who are usually born in a level 2 neonatal ward, with a gestational age of at least 32 0/7 weeks and an expected birth weight >1200 grams. They also can be treated with non-invasive respiratory support, parenteral nutrition, central venous catheters and other medication. Medium care infants: Infants who are usually stable, growing infants without the need for cardiorespiratory monitoring or respiratory support, but can be treated with parenteral nutrition or medication by peripheral venous access. This group also consists of (near-) term smallor large for gestational age infants with glucose monitoring, stable infants treated with antibiotics for suspected perinatal infection, intravenous treatment of hypoglycemia or phototherapy for hyperbilirubinemia. The primary outcome of the AMICA study is neurodevelopment in preterm infants at 2 years of age. 1 We pre-stratified the study population towards infants born <32 weeks of gestation with a previous admission to a level 3 NICU and infants that were born >32 weeks of gestation. Within each gestational age group, we did a power calculation for the primary outcome of neurodevelopment. We calculated to have 64 experimental subjects and 128 control subjects with power 0.90 (1-β) at a significance level of 0.05 (α) with a true difference in the outcome of neurodevelopment of 2 years of ½ SD. To allow for 30% withdrawal we aimed to include 91 patients in group A and 182 patients in group B per risk group (post-intensive care versus inborn infants). A total of 546 infants who were hospitalised and their parents were expected to be included in this study. For this study we calculated the power for the outcome on stress in mothers post-hoc. 6 The group sample sizes of 124 and 115 achieved 93% power to detect a difference of -9.8 between the null hypothesis that both group means are 47.2 and the alternative hypothesis that the mean of group 2 is 57.0 with known group standard deviations of 22.2 and 22.2 and with a significance level (alpha) of 0.05 using a two-sided two-sample t-test. The Parental Stressor Scale:Neonatal Intensive Care Unit (PSS-NICU) is a scale to measure parental perceptions of stressors associated with the hospitalisation of their child. It measures parents' perceptions of stressors arising from the physical and emotional environment. It takes in account the infant's behaviour and appearance, parental role alterations, and the sights and sounds of the environment 7,8 . The PSS-NICU questionnaire has 3 subdomains and measures the degree of stress experienced by parents during hospitalization related to alterations in their parental role, the appearance and behavior of their infant, and sights and sounds of the unit. Parents rate their experiences on a 5point rating scale ranging from "not at all stressful" (0) to "extremely stressful" (5) . In an update of the tool in 2007, sights and sounds of the environment (5 items) were combined with infant's appearance subscale (14 items) and scored as one subscale and Parental Role Alteration as the second subscale (7 items). 9 If mothers did not experience the stressor, we transformed the score to "0". 10 The PSS:NICU has been translated into Dutch and Cronbach alpha of this questionnaire is been shown to be 0.89-0.94 8 . Depression and anxiety scores at discharge were measured with the Hospital Anxiety and Depression scale, which has previously been validated in the Dutch population. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. It has been validated in the Dutch population before in ages 16 to 65 years 11 . The Postpartum Bonding Questionnaire (PBQ), was devised by Brockington et al. (2001) as a screening instrument to detect bonding problems in obstetric and primary care services 12, 13 . The PBQ is a 25-item scale reflecting a mother's feelings or attitudes towards her baby (e.g. ''I feel close to my baby'', ''My baby irritates me''). Participants rate how often they agree with these statements on a 6-point Likert scale ranging from always (score=0) to never (score=5) with low scores denoting good bonding. The PBQ has four subscales which reflect impaired bonding (Scale 1) (12 items, ranging from 0 to 60), rejection and anger (Scale 2) (7 items, scores ranging from 0 to 35), anxiety about care (Scale 3) (4 items, scores ranging from 0 to 20) and risk of abuse (Scale 4) (2 items, scores ranging from 0 to 10). Scale 1 (impaired bonding) has a sensitivity of 0.93 and a specificity of 0.85 in detecting mothers with a bonding disorder. Parent satisfaction was measured using the EMpowerment of PArents in THe Intensive Care -Neonatology questionnaire 14 . This questionnaire was developed and tested in a single center in the Netherlands, and available in Dutch. The domains covered are: Information (14 statements); Care and Treatment (20 statements); Parental Participation (nine statements); Organization (11 statements); and Professional Attitude (13 statements). The 57 statements divided in five domains provide a conceptualization of parent satisfaction within the neonatal ward from a family-centred care perspective 14 . The Perceived (Maternal) Parenting Self-Efficacy (PMP-SE) tool, was used to measure perceived parental self-confidence when caring for the infant admitted to the Neonatal Ward 15 . The internal consistency reliability of the Perceived Maternal Parenting Self-Efficacy tool is 0.91, external/testretest reliability is 0.96. A total of four conceptually unique subscales of parenting are: "Care taking procedures" (parents' perceptions of their ability to perform the activities and tasks related to the baby's basic needs like feeding). "Evoking behaviour(s)" (perceptions in their ability to elicit a change in the baby's behaviour, for example, soothing the baby). "Reading behaviour(s) or signalling" (perceptions in their ability to understand and identify changes in their baby's behaviour, for example, 'I can tell when my baby is sick'). "Situational beliefs"(parents' beliefs about their ability to judge their overall interaction with the baby). Responses to each item were recorded on a four point Likert scale ranging from 'strongly disagree' (score 1) to 'strongly agree' (score 4). A low score on this scale indicates a low parental self-efficacy. We previously validated a measurement tool on parent participation in neonatal care (the CO-PARTNER tool), which includes 6 domains: 1) daily care 2) medical care 3) information gathering 4) advocacy and leadership 5) time spent with infant 6) closeness and comforting the infant. 16 Parents fill out the scale reflecting on a set time-frame by the researchers. In this study, parents reflected on their participation during infant hospital stay up to discharge. Total scores per domain were obtained by summing scores. For Domain 1, 2 and 6 we calculated 0 for 'the nurse does this', 1 for 'the nurse and I do this together' and 2 for 'I do this independently' (minimum scores 0 to 22, 8 and 14 respectively). For domain 3 and 4 'yes' was scored as 1, and 'no' as 0 (minimum scores 0 to 3). Non-applicable items were transformed to 0 (no participation in this item). For the domain Time Spent with Infant (3 items) quartiles were calculated resulting in 0 to 4 score (total score in domain 5 minimum 0 maximum 12). A total participation score was obtained by summing all domain scores. Minimum total scores were 0 and maximum 62. Potential confounders and effect modifiers were identified from the literature and assessed using statistical analyses. We considered socio-economic class (including education and employment status), family composition (single parent vs co-parenting), older/other infants in the family, stress at birth, gestational age of infant, singleton status and mode of delivery. If the beta-regression coefficient differed at least 10% in regression analyses, this was used as an indication of statistical confounding, and the variable was included in the adjusted model. If collinearity was present, the strongest confounder (largest change in crude beta-coefficient) was used to adjust for. eFigure 1. Images of Care Single Family Rooms A. Single family room with complete couplet care for the mother-infant dyad A Single-Family Room for highly complex maternity and neonatal Level 2 Care. Women and their newborns will remain in this suite for as long as both require specialized care, or at least for 7 days if the newborn requires specialized care. Fathers, too, can be present continuously. If after 7 days and one of them no longer needs specialized care, the woman and the newborn are transferred to a smaller single-family room, a room for highly complex maternity care and neonatal level 1 care or a room for neonatal level 2 care. All single-family rooms provide rooming-in facilities for one parent/partner. 5 Copyrights Audiovisuele Zaken, OLVG, Amsterdam, The Netherlands, June 2020. Copyrights Audiovisuele Zaken, OLVG, Amsterdam, The Netherlands, June 2020. Depicted is a family with twin infants born at a gestational age of 32 weeks, together with a doctor and nurse specialized in neonatal care. The family stays continuously together in a single family room in our integrated neonatal-maternity ward. This enables both parents to participate, as equal partners in the medical team, in the care and medical decision making for their infants during hospital stay. Copyrights Audiovisuele Zaken, OLVG, Amsterdam, The Netherlands, June 2020. Variables associated with missing data at discharge were infant gestational age, work status of the mother, cultural background, total length of stay in the hospital, and education level, and used for the multiple imputation model. * at discharge and/or admission and/or 3 months of age, n: number, NA: not applicable, Non-missing Family integrated care in single family rooms for preterm infants and late-onset sepsis: a retrospective study and mediation analysis Perinatale Zorg in Nederland Perinataal beleid bij extreme vroeggeboorte Integration of Maternity and Neonatal Care to Empower Parents Sample Size Tables for Clinical Studies: Third Edition Psychometric properties of the parental stressor scale: Infant hospitalization Parental Stressor Scale: Neonatal Intensive Care Unit Depressive symptoms in mothers of prematurely born infants Rethinking Stress in Parents of Preterm Infants: A Meta-Analysis Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects The Postpartum Bonding Questionnaire: A validation A screening questionnaire for mother-infant bonding disorders Development and validation of a neonatal intensive care parent satisfaction instrument Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool: Development and validation with mothers of hospitalized preterm neonates Three self-report questionnaires of the early mother-to-infant bond: Reliability and validity of the Dutch version of the MPAS, PBQ and MIBS NA / 0 (n) Not at all stressful 2 (n) A little stressful Moderately stressful Very stressful Total answers (n)