scholarly journals Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial

10.2196/17943 ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. e17943
Author(s):  
Jorge Bustamante Loyola ◽  
Marcela Perez Retamal ◽  
Monica Isabel Morgues Nudman ◽  
Andres Maturana ◽  
Ricardo Salinas Gonzalez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Neonatal Intensive Care ◽  
Social Withdrawal ◽  
Controlled Trial ◽  
Late Preterm ◽  
Pediatric Care ◽  
Randomized Controlled ◽  
Guidance Intervention

Background Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. Objective The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms. Methods This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale–revised. Results Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021. Conclusions This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up. Trial Registration ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547. International Registered Report Identifier (IRRID) DERR1-10.2196/17943

scholarly journals Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jorge Bustamante Loyola ◽  
Marcela Perez Retamal ◽  
Monica Isabel Morgues Nudman ◽  
Andres Maturana ◽  
Ricardo Salinas Gonzalez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Neonatal Intensive Care ◽  
Social Withdrawal ◽  
Controlled Trial ◽  
Late Preterm ◽  
Pediatric Care ◽  
Randomized Controlled ◽  
Guidance Intervention

BACKGROUND Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. OBJECTIVE The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms. METHODS This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale–revised. RESULTS Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021. CONCLUSIONS This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up. CLINICALTRIAL ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17943

scholarly journals Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Karen M. Benzies ◽  
◽  
Vibhuti Shah ◽  
Khalid Aziz ◽  
Wanrudee Isaranuwatchai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Level Ii ◽  
Family Integrated Care ◽  
Cluster Randomized ◽  
Family Integrated

Abstract Background Every year, about 15 million of the world’s infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. Methods We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. Discussion Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. Trial registration ClinicalTrials.gov, ID: NCT02879799. Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

The Effect of Supportive Nursing Interventions on Reducing Stress Levels of Mothers of Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial

2021 ◽  
pp. 105477382110473
Author(s):  
Gamze Yilmaz ◽  
Dilek Küçük Alemdar
Keyword(s):  
Intensive Care Unit ◽  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Neonatal Intensive Care Unit ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Nursing Interventions ◽  
Randomized Controlled ◽  
Supportive Interventions ◽  
Reducing Stress

The purpose of this study was to determine the effects of supportive interventions on the stress levels of mothers with infants hospitalized in the Neonatal Intensive Care Unit (NICU). This study was a prospective, pre-and post-test randomized controlled trial. The research was completed with 85 mothers in two groups of 45 subjects and 40 controls selected at random. Data collection used the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU), NICU Parent Belief Scale (NICU:PBS), State-Trait Anxiety Inventory (STAI TX-2) and saliva cortisol analysis. There were statistically significant differences in favor of the experiment group for the PSS:NICU images and sounds subscale and PBS total points after supportive interventions ( p < .05). Supportive nursing interventions were effective in reducing stress related to the intensive care environment, anxiety levels and saliva cortisol levels and increasing parental belief among mothers.

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