Pain responses in preterm infants and parental stress over repeated painful procedures: a randomized pilot trial.

OBJECTIVES: In this pilot study, the aims were to determine the feasibility of whether pain behavior in extremely and very preterm infants and perceived parental stress change when parents are involved in pain reducing measures, either actively, performing facilitated tucking or passively, observing the intervention, in comparison to the involvement of nurses only. In addition, the infant's pain reactivity and parental stress over three time points of measurement was of interest. METHODS: Extremely and very preterm infants in need of subcutaneous erythropoietin were randomly assigned to the two intervention groups. The intervention encompassed that one parent of each infant was involved during the painful procedure: Either parents executed facilitated tucking themselves or stood by, observing the procedure. Usual care involved that nurse executed facilitated tucking. All infants received 0.5 ml of 30% oral glucose solution via cotton swab before the painful procedure. Infant pain was observed with the Bernese Pain Scale for Neonates (BPSN) and measured with the MedStorm skin conductance algesimeter (SCA) before, during, and after the procedure. Parents' stress levels were measured before and after the painful procedure on the infant, using the Current Strain Short Questionnaire (CSSQ). Feasibility of a subsequent trial was determined by assessing recruitment, measurement and active parental involvement. Quantitative data collection methods (i.e. questionnaires, algesimeter) were employed to determine the number of participants for a larger trial and measurement adequacy. Qualitative data (interviews) was employed to determine parents' perspectives of their involvement. RESULTS: A total of 13 infants (98% participation rate) were included along with their mothers. Median gestational age was 27 weeks (IQR 26-28 weeks), 62% were female. Two infants (12.5%) dropped out of the study as they were transferred to another hospital. Facilitated tucking turned out to be a good method to actively involve parents in pain reducing measures. No significant differences between the two intervention and control groups were found concerning parental stress and infant pain (p = .927). Power analysis indicated that at least N = 741 infants (power of 81%, α = .05) would be needed to obtain statistically significant results in a larger trial, as effect sizes were smaller than expected. Two of the three measurement tools - i.e. the BPSN and CSSQ) - proved easy to implement and were well accepted. owever, the SCA was challenging in this context. Measurements were also found to be time-consuming and resource-intense (i.e. health professionals as assistants). CONCLUSIONS: Although the intervention was feasible and was readily accepted by parents, the study design was found to be challenging along with the SCA. In preparation of the larger trial, the study design needs to be revisited and adjusted. Thus, issues of time and resources may be resolved. In addition, national and international collaboration with similar neonatal intensive care units (NICU) needs to be considered. Thus, it will be possible to conduct an appropriately powered larger trial, which will yield important results to improve pain management in extremely and preterm infants in NICU.

Enhancing Parents' Well-Being after Preterm Birth-A Qualitative Evaluation of the "Transition to Home" Model of Care.

There are few programs available aimed at preventing short- and long-term negative consequences after preterm birth and covering the entire care continuum. The "Transition to Home (TtH)" model is such a program, offering structured, individual support for families with preterm infants before and after hospital discharge. This study gathers and examines the parents' views of receiving support from an interprofessional team under the TtH model of care during hospitalization and after discharge. Using a qualitative explorative design, 39 semi-structured interviews with parents were analyzed thematically. From this analysis, three main themes were identified: (1) TtH and the relevance of continuity of care; (2) Enhancement of parents' autonomy and self-confidence; (3) Perception of interprofessional collaboration. Within these themes, the most relevant aspects identified were continuity of care and the appointment of a designated health care professional to anchor the entire care continuum. Emotional support complemented by non-medical approaches, along with strength-based and family resource-oriented communication, also emerged as key aspects. Continuous, family-centered care and well-organized interprofessional collaboration promote the well-being of the family after a premature birth. If the aspects identified in this study are applied, the transition from hospital to home will be smoothened for the benefit of affected families.

Systematic Review of the Effectiveness of Involving Parents During Painful Interventions for Their Preterm Infants.

OBJECTIVE: To systematically review the literature related to the effectiveness of parents' active involvement during painful interventions for their preterm infants. DATA SOURCES: We performed a systematic search of PubMed, EMBASE/Ovid, CINAHL, Livivio, and PsycInfo using the keywords "preterm infants," "pain," and "parents." STUDY SELECTION: Articles were eligible for inclusion if they were published between 2000 and 2021 and reported randomized controlled trials (RCTs) in which preterm infants underwent painful interventions, and parents were present and actively involved in pain-reducing measures. DATA EXTRACTION: We used the Consolidated Standards of Reporting Trials (CONSORT) checklist for RCTs for data extraction. We assessed methodologic quality using critical appraisal for RCTs according to the Joanna Briggs Institute. DATA SYNTHESIS: In total, 22 articles met the inclusion criteria. These articles reported 19 studies focused on kangaroo/skin-to-skin care, one focused on breastfeeding, and two focused on facilitated tucking. The methods used to evaluate pain in the infant varied substantially. Overall, kangaroo/skin-to-skin care and facilitated tucking resulted in clinically and statistically significant decreases in pain. For breastfeeding, effectiveness was linked to a more mature sucking pattern of the preterm infant. CONCLUSION: The current evidence suggests that involving parents in pain-reducing measures during painful interventions for their preterm infants is beneficial. However, more research is needed for the different methods of involving parents in pain-reducing measures.

Interprofessional Collaboration in a New Model of Transitional Care for Families with Preterm Infants - The Health Care Professional's Perspective.

BACKGROUND: Families with preterm infants find life after hospital discharge challenging and need tailored support to thrive. The "Transition to Home (TtH)"-model offers structured, individual support for families with preterm infants before and after hospital discharge. TtH improves parental mental health and competence, promotes child development and fosters interprofessional collaboration (IPC). AIM: Evaluate the TtH-models' structure and implementation process and its associated interprofessional collaboration from the healthcare professional's (HCP) perspective. METHODS: This qualitative explorative study thematically analyzed four focus group interviews (n=28 HCP) and an open-ended questionnaire with general pediatricians (n=8). RESULTS: The main themes of the thematic analysis were the benefits of the TtH-model, tailored parental support, the challenges of changing interprofessional collaboration, facilitators and barriers to successfully implementing the model, and feasibility and health economic limits. HCP acknowledge that continuous family-centered care led by an advanced practice nurse (APN) supports, strengthens, and relieves families with preterm infants in the transition from hospital to home. Families in complex situations benefit most. The TtH-model incorporates key aspects of integrated care like shared decision-making, considering family preferences, and defining the APN as the family's main contact. HCP want network collaboration but found communication, cooperation, and reorganization challenging in the new IPC process. IPC challenges and involving many HCP in family care can create parental oversupply, negatively affect treatment outcomes, and raise health care costs. CONCLUSION: These challenges need to be addressed to ensure sustainable implementation of the model. The roles and tasks of HCP should be clearly distinguished from each other, and HCP must have time to learn this new form of IPC. Learning requires time, effective communication strategies, and leadership support. Political action is also required to implement new models of care, including regulating advanced practice roles and developing new financing models.

Euphrasia Eye Drops in Preterm Neonates With Ocular Discharge: A Randomized Double-Blind Placebo-Controlled Trial.

Aim: To investigate whether the early administration of Euphrasia eye drops® in preterm neonates presenting with ocular discharge fosters the resolution of the ocular discharge and reduces the need for topical antibiotic therapy, as compared to placebo. Methods: We conducted a randomized double-blind placebo-controlled trial at the University Children's Hospital Bern, Switzerland. Preterm neonates with white, yellow, or green ocular discharge were included. Infants were randomly assigned (1:1) to the Euphrasia arm (Euphrasia eye drops®, Weleda AG, Arlesheim) or the placebo arm (NaCl 0.9%). Euphrasia or placebo was administrated at a dose of one drop in each eye four times a day over a period of 96 h. The primary outcome was the treatment success, defined as no ocular discharge at 96 h and no use of topical antibiotic therapy during the 96-h intervention. Results: A total of 114 neonates were screened and 84 were randomized. Among neonates in the Euphrasia arm, 22 (55.0%) achieved our primary outcome compared to 21 (51.2%) in the placebo arm (p = 0.85). In the Euphrasia arm, time to resolution of reddening tended to fall within the shorter bracket of 24 to 48 h (24 (92.3%) vs. 12 (80.0%) in the placebo arm, p = 0.34) and relapse or first signs of reddening during the 96-h intervention tended to be lower [3 (7.9%) eyes vs. 8 (18.2%) eyes in the placebo arm, p = 0.17]. Tearing at 96 h tended to be lower in the Euphrasia arm [5 (12.8%) eyes in the Euphrasia arm vs. 12 (27.3%) eyes in the placebo arm, p = 0.10]. Discussion: Euphrasia did not significantly improve treatment success, defined as no ocular discharge at 96 h and no use of topical antibiotic therapy during the 96-h intervention. However, results suggest that Euphrasia may be of benefit for symptoms such as reddening and tearing, and thus improve the comfort of patients. Trial Registration: The trial is registered at the US National Institutes of Health (ClinicalTrials.gov) NCT04122300 and at the portal for human research in Switzerland SNCTP000003490.

The influence of gestational age in the psychometric testing of the Bernese Pain Scale for Neonates.

BACKGROUND: Assessing pain in neonates is challenging because full-term and preterm neonates of different gestational ages (GAs) have widely varied reactions to pain. We validated the Bernese Pain Scale for Neonates (BPSN) by testing its use among a large sample of neonates that represented all GAs. METHODS: In this prospective multisite validation study, we assessed 154 neonates between 24 2/7 and 41 4/7 weeks GA, based on the results of 1-5 capillary heel sticks in their first 14 days of life. From each heel stick, we produced three video sequences: baseline; heel stick; and, recovery. Five blinded nurses rated neonates' pain responses according to the BPSN. The underlying factor structure of the BPSN, interrater reliability, concurrent validity with the Premature Infant Pain Profile-Revised (PIPP-R), construct validity, sensitivity and specificity, and the relationship between behavioural and physiological indicators were explored. We considered GA and gender as individual contextual factors. RESULTS: The factor analyses resulted in a model where the following behaviours best fit the data: crying; facial expression; and, posture. Pain scores for these behavioural items increased on average more than 1 point during the heel stick phases compared to the baseline and recovery phases (p < 0.001). Among physiological items, heart rate was more sensitive to pain than oxygen saturation. Heart rate averaged 0.646 points higher during the heel stick than the recovery phases (p < 0.001). GA increased along with pain scores: for every additional week of gestation, the average increase of behavioural pain score was 0.063 points (SE = 0.01, t = 5.49); average heart rate increased 0.042 points (SE = 0.01, t = 6.15). Sensitivity and specificity analyses indicated that the cut-off should increase with GA. Modified BPSN showed good concurrent validity with the PIPP-R (r = 0.600-0.758, p < 0.001). Correlations between the modified behavioural subscale and the item heart rate were low (r = 0.102-0.379). CONCLUSIONS: The modified BPSN that includes facial expression, crying, posture, and heart rate is a reliable and valid tool for assessing acute pain in full-term and preterm neonates, but our results suggest that adding different cut-off points for different GA-groups will improve the BPSN's clinical usefulness. TRIAL REGISTRATION: The study was retrospectively registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461 . Registration date: 12 April 2016.

Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study.

BACKGROUND: The Bernese Pain Scale for Neonates (BPSN) is a multidimensional pain assessment tool that is already widely used in clinical settings in the German speaking areas of Europe. Recent findings indicate that pain responses in preterm neonates are influenced by individual contextual factors, such as gestational age (GA), gender and the number of painful procedures experienced. Currently, the BPSN does not consider individual contextual factors. Therefore, the aim of this study is the validation of the BPSN using a large sample of neonates with different GAs. Furthermore, the influence of individual contextual factors on the variability in pain reactions across GA groups will be explored. The results will be used for a modification of the BPSN to account for individual contextual factors in future clinical pain assessment in neonates. METHODS AND DESIGN: This prospective multisite validation study with a repeated measures design will take place in three university hospital neonatal intensive care units (NICUs) in Switzerland (Bern, Basel and Zurich). To examine the impact of GA on pain responses and their variability, the infants will be stratified into six GA groups ranging from 24 0/7 to 42 0/7. Among preterm infants, 2-5 routine capillary heel sticks within the first 14 days of life, and among full-term infants, two heel sticks during the first days of life will be documented. For each heel stick, measurements will be video recorded for each of three phases: baseline, heel stick, and recovery. The infants' pain responses will be rated according to the BPSN by five nurses who are blinded as to the number of each heel stick and as to the measurement phases. Individual contextual factors of interest will be extracted from patient charts. DISCUSSION: Understanding and considering the influence of individual contextual factors on pain responses in a revised version of the BPSN will help the clinical staff to more appropriately assess pain in neonates, particularly preterm neonates hospitalized in NICUs. Pain assessment is a first step toward appropriate and efficient pain management, which itself is an important factor in later motor and cognitive development in this vulnerable patient population. TRIAL REGISTRATION: The study is registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461 . Registration date: 12 April 2016.

Physiological parameters after nonpharmacological analgesia in preterm infants: a randomized trial.

AIM: To compare the influence of three different nonpharmacological interventions on cortical activation, heart rate and peripheral oxygen saturation (SaO2 ) after heelstick in preterm infants. METHODS: Twenty five preterm infants between 24 0/7 and 32 0/7 weeks of gestational age were randomized to either oral sucrose (S), facilitated tucking (FT) or a combination of the two interventions (SFT) prior to five heelsticks each within the first 14 days of life. SaO2 , heart rate and oxygenation of the somatosensory cortex, measured by near infrared spectroscopy (NIRS), were analysed. RESULTS: Hundred and twenty five heelsticks were performed. The heart rate increased significantly after heelstick in all three intervention groups (p < 0.004 in all groups). The increase was higher in the FT group compared with the other groups (S: p = 0.007; SFT: p = 0.004). There was no difference among the two groups receiving sucrose (S and SFT; p = 0.87). SaO2 did not change significantly after heelstick in all intervention groups. Near infrared spectroscopy measurements did not show a significant change in the curve but patients in the FT group showed a trend towards higher average oxygenation of the contralateral somatosensory cortex. CONCLUSION: Oral sucrose seems to be more effective in reducing reaction to pain than FT. Application of both interventions did not show an additive effect.