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A guided participation nursing intervention to theraupeutic positioning and care (GP_Posit) for mothers of preterm infants: protocol of a pilot randomized controlled trial.

ABSTRACT: Background:In the NICU, interventions intended to enhance maternal sensitivity are indicated in order to optimize preterm infant development and long-term mother-infant attachment. A novel nursing intervention was developed following a theory-oriented methodology and is based upon the guided participation theory for mothers to participate in their preterm infant's therapeutic POSITioning and care (GP_Posit). The primary objective of this study is to evaluate the feasibility and acceptability of (i) the study design; and (ii) the experimental GP_Posit nursing intervention during NICU hospitalization. The secondary objective is to estimate the preliminary effects of GP_Posit on maternal and preterm infant outcomes. Methods:A pilot parallel-group randomized clinical trial (RCT) was designed where mother-preterm infant dyads are being recruited and randomized to a control group (usual care) or experimental group (GP_Posit intervention). Data collection includes feasibility and acceptability data as well as preliminary effects on maternal sensitivity and infant neurodevelopment. Ethical approval from the University Hospital ethical board was obtained in January 2018 (2017-1540). Discussion:Data collection for this pilot study is expected to end in 2020. Results of this pilot study will inform about the feasibility and acceptability of the study design and GP_Posit intervention, a nursing intervention having the potential to favor maternal sensitivity and infant neurodevelopment in the NICU and guide the elaboration of a large-scale RCT. Trial registration:clinicaltrial.gov, NCT03677752. Registered 19 September 2018.

SUBMITTER: Lavallee A

PROVIDER: S-EPMC7251724 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A guided participation nursing intervention to theraupeutic positioning and care (GP_Posit) for mothers of preterm infants: protocol of a pilot randomized controlled trial.

Lavallée Andréane A Aita Marilyn M Côté José J Bell Linda L Luu Thuy Mai TM

Pilot and feasibility studies 20200526

<h4>Background</h4>In the NICU, interventions intended to enhance maternal sensitivity are indicated in order to optimize preterm infant development and long-term mother-infant attachment. A novel nursing intervention was developed following a theory-oriented methodology and is based upon the guided participation theory for mothers to participate in their preterm infant's therapeutic POSITioning and care (GP_Posit). The primary objective of this study is to evaluate the feasibility and acceptabi ...[more]

PMID: 32509322

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Project description:BackgroundMulti-sensory behavioral interventions for preterm infants have the potential to accelerate feeding, growth, and optimize developmental trajectories and increase parents' interactive engagement with their infants. However, few neonatal intensive care units (NICUs) provide evidence-based standardized early behavioral interventions as routine care. Lack of implementation is a major gap between research and clinical practice. H-HOPE, is a standardized behavioral intervention with an infant- directed component (Massage+) and a parent-directed component (four participatory guidance sessions that focus on preterm infants' behaviors and appropriate responses). H-HOPE has well documented efficacy. The purpose of this implementation study is to establish H-HOPE as the standard of care in 5 NICUs.MethodsThe study employs a Type 3 Hybrid design to simultaneously examine the implementation process and effectiveness in five NICUs. To stagger implementation across the clinical sites, we use an incomplete stepped wedge design. The five participating NICUs were purposively selected to represent different acuity levels, number of beds, locations and populations served. Our implementation strategy integrates our experience conducting H-HOPE and a well-established implementation model, the Consolidated Framework for Implementation Research (CFIR). The CFIR identifies influences (facilitators and barriers) that affect successful implementation within five domains: intervention characteristics, outer setting (the hospital and external events and stakeholders), inner setting (NICU), implementers' individual characteristics, and the implementation process. NICUs will use the CFIR process, which includes three phases: Planning and Engaging, Executing, and Reflecting and Evaluating. Because sustaining is a critical goal of implementation, we modify the CFIR implementation process by adding a final phase of Sustaining.DiscussionThis study builds on the CFIR, adding Sustaining H-HOPE to observe what happens when sites begin to maintain implementation without outside support, and extends its use to the NICU acute care setting. Our mixed methods analysis systematically identifies key facilitators and barriers of implementation success and effectiveness across the five domains of the CFIR. Long term benefits have not yet been studied but may include substantial health and developmental outcomes for infants, more optimal parent-child relationships, reduced stress and costs for families, and substantial indirect societal benefits including reduced health care and special education costs.Trial registrationClinicalTrials.gov registration number NCT04555590 , Registered on 8/19/2020.

Project description:BACKGROUND:Previous studies showed that parents of very preterm infants expressed feelings of incompetence and experienced high levels of stress upon the discharge of their infants. We conducted a systematic review of seven studies and observed potential benefits for parental outcomes when using discharge interventions that adopted guided participation (GP). More evidence is needed on the effective doses of discharge interventions underpinned by the principles of GP. AIM:To investigate the feasibility and preliminarily estimate the effects on parental competence and stress outcomes of a newly developed, nurse-led, GP discharge program for mothers of very preterm infants. METHODS:A two-arm randomized controlled trial was conducted in a neonatal intensive care unit (NICU). Mothers of infants with gestational ages of ?32?weeks who had no congenital malformations and did not need to undergo major surgeries were recruited. All mothers were the primary caregivers to their infants. The intervention group received a nurse-led GP discharge intervention (three structured 30- to 60-min GP sessions and one follow-up phone call). The control group received usual care. The parental outcomes were measured using the Parenting Sense of Competence Scale (C-PSOC) and Perceived Stress Scale (C-PSS) at baseline (T0), on the day of discharge (T1), after the follow-up phone call (within 72?h after discharge) (T2), and 1?month after discharge (T3). The outcomes were analyzed using generalized estimating equations based on intention-to-treat principles. RESULTS:Thirty infant-mother dyads were recruited. Greater improvements in the C-PSOC score were observed in the intervention group than in the control group at T1 and T2, although these differences were statistically insignificant. The intervention group exhibited greater improvements than the control group in the C-PSS scores at T1, T2, and T3, although these differences were also not statistically significant. CONCLUSIONS:The findings suggest that a GP discharge intervention could improve parenting competence and stress among mothers with very preterm infants. The absence of adverse events suggests that the GP discharge intervention could be feasibly implemented in NICU settings. This feasibility study was not powered to determine the effectiveness of the intervention but is anticipated to lay the foundation for a future full-scale study. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03668912. Date of registration: 13 September 2018 (retrospectively registered).

Project description:BACKGROUND:Preterm infants are high risk for delayed neurodevelopment. The main goal is to develop a program of early intervention for very preterm infants that allows families to apply it continuously at home, and quantify the results of early parental stimulation on improvement of cognition and motor skills. METHODS:Randomized clinical Trial including inborn preterm infants with gestational age less than 32 weeks or birth weight less than 1500 g at 48 h after birth. Eligible for begin the intervention up to 7 days after birth. Study Protocol approved by the Brazilian national Committee of ethics in Research and by the institutional ethics committee. Intervention group (IG): skin-to skin care by mother (kangaroo care) plus tactile-kinesthetic stimulation by mothers from randomization until hospital discharge when they receive a program of early intervention with 10 parents' orientation and a total of 10 home visits independently of the standard evaluation and care that will be performed. Systematic early intervention program will be according to developmental milestones, anticipating in a month evolutionary step acquisition of motor and / or cognitive expected for corrected age. Active comparator with a Conventional Group (CG): standard care according to the routine care of the NICU and their needs in the follow up program. Neurodevelopment outcome with blinded evaluations in both groups between 12 and 18 months by Bayley Scales of Infant and Toddler Development third edition and Alberta Motor Infant scale will be performed. All evaluations will be conducted in the presence of parents or caregivers in a safe room for the child move around during the evaluation. DISCUSSION:If we can show that a continuous and global early intervention at home performed by low income families is better than the standard care for very preterm infants, this kind of program may be applied elsewhere in the world. We received grants by Bill and Melinda Gates Foundation, DECIT, Cnpq and Health Ministry. Grand Challenges Brazil: All Children Thriving. TRIAL REGISTRATION:The study was restrospectively registered in ClinicalTrials.gov . in July 15 2016 ( NCT02835612 ).

Project description:IntroductionMothers are often the primary caregivers for children requiring heart transplantation. Given that a mother's ability to successfully cope with the demands of her caregiving role may be predictive of positive familial psychosocial outcomes, it is critical that maternal coping is assessed and supported in paediatric healthcare. Mindfulness-based programmes are proposed as one intervention that may enhance quality of life, improve distress tolerance and coping and reduce social isolation in caregiving populations. This pilot study aims to investigate: (1) the implementation success of a mindfulness-based retreat (MBR), and (2) the effectiveness of a MBR at improving quality of life, distress tolerance, coping and perceived social support for mothers of paediatric heart transplant recipients.Methods and analysisA convergent parallel, mixed-method design is proposed for this pilot, exploratory study. Twenty mothers will participate in this pilot MBR held at a resort in Ontario, Canada. Quantitative data will be obtained using five standardised instruments completed at three time points: (T1) 24-hours prior to the intervention, (T2) immediately on completion of the intervention, and (T3) three months post-intervention. Qualitative data will be collected from all participants both through semi-structured focus groups at T2 and individual telephone interviews at T3. Focus groups and individual interviews will be transcribed verbatim for thematic analysis. Quantitative and qualitative data will be merged and compared during interpretation to ensure that the intervention implementation and effectiveness of the MBR retreat are described with comprehensive accuracy. The primary outcomes will be feasibility in relation to implementation effectiveness and participants' perception of social support for efficacy of the MBR intervention.Ethics and disseminationThis study received Institutional Research Ethics Board approval from The Hospital for Sick Children (Number: 1000064719). Informed consent will be obtained prior to participant enrolment. Findings will be disseminated via conference presentations and submitted for publication in a peer-reviewed journal.

Project description:BACKGROUND:Although breast milk has numerous benefits for infants' development, with greater effects in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter breastfeeding duration than mothers of term infants. One of the explanations proposed is the difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home environment. A person-centred proactive telephone support intervention after discharge from NICU is expected to promote mothers' sense of trust in their own capacity and thereby facilitate breastfeeding. METHODS/DESIGN:A multicentre randomized controlled trial has been designed to evaluate the effectiveness and cost-effectiveness of person-centred proactive telephone support on breastfeeding outcomes for mothers of preterm infants. Participating mothers will be randomized to either an intervention group or control group. In the intervention group person-centred proactive telephone support will be provided, in which the support team phones the mother daily for up to 14 days after hospital discharge. In the control group, mothers are offered a person-centred reactive support where mothers can phone the breastfeeding support team up to day 14 after hospital discharge. The intervention group will also be offered the same reactive telephone support as the control group. A stratified block randomization will be used; group allocation will be by high or low socioeconomic status and by NICU. Recruitment will be performed continuously until 1116 mothers (I: 558 C: 558) have been included. PRIMARY OUTCOME:proportion of mothers exclusively breastfeeding at eight weeks after discharge. SECONDARY OUTCOMES:proportion of breastfeeding (exclusive, partial, none and method of feeding), mothers satisfaction with breastfeeding, attachment, stress and quality of life in mothers/partners at eight weeks after hospital discharge and at six months postnatal age. Data will be collected by researchers blind to group allocation for the primary outcome. A qualitative evaluation of experiences of receiving/providing the intervention will also be undertaken with mothers and staff. DISCUSSION:This paper presents the rationale, study design and protocol for a RCT providing person-centred proactive telephone support to mothers of preterm infants. Furthermore, with a health economic evaluation, the cost-effectiveness of the intervention will be assessed.

Project description:INTRODUCTION:Many women cease breastfeeding earlier than desired. This study examined the cessation of breastfeeding among mothers of preterm infants. Thus, the aim was to describe the cessation of breastfeeding in mothers of preterm infants up to 12 months after birth. METHOD:This mixed methods study used a convergent design with both qualitative data, consisting of written comments, and quantitative data, on breastfeeding status and breastfeeding satisfaction. The data were collected from questionnaires sent to the mothers at three points during the first year after birth. In total, 270 mothers of preterm infants who breastfed at the time of discharge from the neonatal unit provided data for the study. The quantitative and qualitative data were analysed separately with statistical tests and hermeneutical analysis, respectively and then together according to the convergent mixed methods design. RESULTS:Four themes of the meanings of the cessation of breastfeeding were identified in the qualitative analysis: "Desire to regain the mother's and the infant's well-being", "The mothers interpretation that the infants actively ceased breastfeeding", "The mother's body and/or the infants' signals showing the way" and "The mother's own will and perceived external obstacles". Mothers who did not breastfeed as long as they wanted were more likely to report less satisfaction with breastfeeding, a shorter breastfeeding period, and less activity when ceasing breastfeeding. In comparison, mothers who breastfed as long as they wanted were more satisfied with breastfeeding, breastfed for a longer period of time and were more active in decision making in breastfeeding cessation. CONCLUSION:Maternal passivity or activity influenced the cessation of breastfeeding in mothers of preterm infants who breastfed at the time of discharge from the neonatal unit. Passive behaviour related to breastfeeding may result in early cessation of breastfeeding, and low breastfeeding satisfaction while active behaviour may increase breastfeeding length and satisfaction.

Dataset Information

A guided participation nursing intervention to theraupeutic positioning and care (GP_Posit) for mothers of preterm infants: protocol of a pilot randomized controlled trial.

Publications

A guided participation nursing intervention to theraupeutic positioning and care (GP_Posit) for mothers of preterm infants: protocol of a pilot randomized controlled trial.

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