Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study.

INTRODUCTION: Oral sucrose is repeatedly administered to neonates in the neonatal intensive care unit (NICU) to treat pain from commonly performed procedures; however, there is limited evidence on its long-term cumulative effect on neurodevelopment. We examined the association between total sucrose volumes administered to preterm neonates for pain mitigation in the NICU and their neurodevelopment at 18 months of corrected age (CA). METHODS: A prospective longitudinal single-arm observational study that enrolled hospitalised preterm neonates <32 weeks of gestational age at birth and <10 days of life was conducted in four level III NICUs in Canada. Neonates received 0.1 mL of 24% sucrose 2 min prior to all commonly performed painful procedures during their NICU stay. Neurodevelopment was assessed at 18 months of CA using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Multiple neonatal and maternal factors known to affect development were adjusted for in the generalised linear model analysis. RESULTS: 172 preterm neonates were enrolled and 118 were included in the analysis at 18 months of CA. The total mean sucrose volume administered/neonate/NICU stay was 5.96 (±5.6) mL, and the mean Bayley-III composite scores were: cognitive 91 (±17), language 86 (±18) and motor 88 (±18). There was no association between Bayley-III scores and the total sucrose volume: cognitive (p=0.57), language (p=0.42) and motor (p=0.70). CONCLUSION: Cumulative sucrose exposure for repeated procedural pain in preterm neonates was neither associated with a delay in neurodevelopment nor neuroprotective effects at 18 months of CA. If sucrose is used, we suggest the minimally effective dose combined with other non-pharmacological interventions with demonstrated effectiveness such as skin-to-skin contact, non-nutritive sucking, facilitated tucking and swaddling. TRIAL REGISTRATION NUMBER: NCT02725814.

A longitudinal observational study on the epidemiology of painful procedures and sucrose administration in hospitalized preterm neonates.

Although sucrose is widely administered to hospitalized infants for single painful procedures, total sucrose volume during the entire neonatal intensive care unit (NICU) stay and associated adverse events are unknown. In a longitudinal observation study, we aimed to quantify and contextualize sucrose administration during the NICU stay. Specifically, we investigated the frequency, nature, and severity of painful procedures; proportion of procedures where neonates received sucrose; total volume of sucrose administered for painful procedures; and incidence and type of adverse events. Neonates <32 weeks gestational age at birth and <10 days of life were recruited from four Canadian tertiary NICUs. Daily chart reviews of documented painful procedures, sucrose administration, and any associated adverse events were undertaken. One hundred sixty-eight neonates underwent a total of 9093 skin-breaking procedures (mean 54.1 [±65.2] procedures/neonate or 1.1 [±0.9] procedures/day/neonate) during an average NICU stay of 45.9 (±31.4) days. Pain severity was recorded for 5399/9093 (59.4%) of the painful procedures; the majority (5051 [93.5%]) were heel lances of moderate pain intensity. Sucrose was administered for 7839/9093 (86.2%) of painful procedures. The total average sucrose volume was 5.5 (±5.4) mL/neonate or 0.11 (±0.08) mL/neonate/day. Infants experienced an average of 7.9 (±12.7) minor adverse events associated with pain and/or sucrose administration that resolved without intervention. The total number of painful procedures, sucrose volume, and incidence of adverse events throughout the NICU stay were described addressing an important knowledge gap in neonatal pain. These data provide a baseline for examining the association between total sucrose volume during NICU stay and research on longer-term behavioral and neurodevelopmental outcomes.

The effectiveness of repeated sucrose for procedural pain in neonates in a longitudinal observational study.

Goal: To determine the analgesic effectiveness of repeated sucrose administration for skin-breaking (SB) procedures over the Neonatal Intensive Care Unit (NICU) hospitalization of preterm infants. Methods: Longitudinal observational study, conducted in four level III Canadian NICUs. Eligible infants were <32 weeks gestational age at birth, and <10 days of life at enrollment. Infants received 24% sucrose (0.12 ml) prior to all painful procedures. The Premature Infant Pain Profile - Revised (PIPP-R) was used at 30 and 60 seconds after a medically-required SB procedure as soon as possible after enrollment and weekly up to three additional times for scheduled procedures. Results: 172 infants (57.3% male, gestational age 28.35 (±2.31) weeks) were included. The mean 30 s PIPP-R scores were 6.11 (±3.68), 5.76 (±3.41), 6.48 (±3.67), and 6.81 (±3.69) respectively; there were no statistically significant interactions of study site by time (p = 0.31) or over time (p = 0.15). At 60 s, mean PIPP-R scores were 6.05 (±4.09), 5.74 (±3.67), 6.19 (±3.7), and 5.99 (±3.76) respectively; there were no study site by time interactions (p = 0.14) or differences over time (p = 0.52). There was a statistically significant site difference in the effectiveness of sucrose at 30 and 60 seconds (p < 0.01). Conclusions: Consistently low PIPP-R scores following a skin-breaking procedure indicated that the analgesic effectiveness of the minimal dose of sucrose was sustained over time in the NICU. Further research is required to determine the optimal combination of sucrose and other pain management strategies to improve clinical practice and the impact of consistent use of repeated use of sucrose on neurodevelopment.

A cluster randomized clinical trial to evaluate the effectiveness of the Implementation of Infant Pain Practice Change (ImPaC) Resource to improve pain practices in hospitalized infants: a study protocol.

BACKGROUND: Hospitalized infants undergo multiple painful procedures daily. Despite the significant evidence, procedural pain assessment and management continues to be suboptimal. Repetitive and untreated pain at this vital developmental juncture is associated with negative behavioral and neurodevelopmental consequences. To address this knowledge to practice gap, we developed the web-based Implementation of Infant Pain Practice Change (ImPaC) Resource to guide change in healthcare professionals' pain practice behaviors. This protocol describes the evaluation of the intervention effectiveness and implementation of the Resource and how organizational context influences outcomes. METHODS: An effectiveness-implementation hybrid type 1 design, blending a cluster randomized clinical trial and a mixed-methods implementation study will be used. Eighteen Neonatal Intensive Care Units (NICUs) across Canada will be randomized to intervention (INT) or standard practice (SP) groups. NICUs in the INT group will receive the Resource for six months; those in the SP group will continue with practice as usual and will be offered the Resource after a six-month waiting period. Data analysts will be blinded to group allocation. To address the intervention effectiveness, the INT and SP groups will be compared on clinical outcomes including the proportion of infants who have procedural pain assessed and managed, and the frequency and nature of painful procedures. Data will be collected at baseline (before randomization) and at completion of the intervention (six months). Implementation outcomes (feasibility, fidelity, implementation cost, and reach) will be measured at completion of the intervention. Sustainability will be assessed at six and 12 months following the intervention. Organizational context will be assessed to examine its influence on intervention and implementation outcomes. DISCUSSION: This mixed-methods study aims to determine the effectiveness and the implementation of a multifaceted online strategy for changing healthcare professionals' pain practices for hospitalized infants. Implementation strategies that are easily and effectively implemented are important for sustained change. The results will inform healthcare professionals and decision-makers on how to address the challenges of implementing the Resource within various organizational contexts. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03825822. Registered 31 January 2019.

Postdischarge Feeding of Very-low-birth-weight Infants: Adherence to Nutrition Guidelines.

OBJECTIVES: Infant feeding guidelines are important public health strategies to promote optimal growth, development, and chronic disease prevention, but their effectiveness is contingent upon families' ability to adhere to them. Little is known of adherence to guidelines among nutritionally vulnerable infants, specifically those born very-low-birth-weight (VLBW) (<1500 g). This study investigated whether postdischarge feeding practices for VLBW infants align with current recommendations and explored parental and infant baseline sociodemographics related to these practices. METHODS: Prospectively collected data from families of 300 VLBW infants participating in a randomized clinical trial (ISRCTN35317141) were used. Baseline demographics were obtained at enrollment and postdischarge feeding practices via monthly telephone questionnaires to 6 months corrected age (CA). RESULTS: At discharge, 4 and 6 months CA, 72%, 39%, and 29% of infants received any amount of mother's milk, respectively; exclusive breast-feeding rates were 49%, 20%, and 6%, respectively. Among infants receiving mother's milk, rates of vitamin D supplementation were ≥83%. Recommendations for introducing solids between 4 and 6 months CA were followed by 71% of the cohort and for iron supplementation by 58%. Overall, 12% of infants adhered to all aforementioned recommendations. Mothers with university degrees were more likely to provide mother's milk, whereas mothers of Middle Eastern/South Asian ethnicity were less likely to provide mother's milk. CONCLUSIONS: Low rates of partial and exclusive breast-feeding of VLBW infants to 6 months CA were reported. Overall adherence to iron supplementation was low. Strategies to provide increased support for mothers identified as at-risk should be developed.

Cost-Effectiveness of Supplemental Donor Milk Versus Formula for Very Low Birth Weight Infants.

OBJECTIVES: To determine the cost-effectiveness of supplemental donor human milk (DHM) versus preterm formula (PTF) for very low birth weight (VLBW, <1500 g) infants from a societal perspective to 18 months' corrected age. METHODS: This prospective cost-effectiveness analysis of 363 VLBW infants was conducted for a randomized control trial. Infants recruited from October 2010 to December 2012 were fed DHM or PTF whenever mother's milk was unavailable. Formal health care costs for initial hospitalization and readmissions were obtained from standardized cost-accounting systems and physician fees. Informal and nonhealth care sector costs (eg, caregiver transportation, labor market earnings) were calculated from parent reports. RESULTS: Mean infant birth weight was 996 (SD, 272) grams. Incidence of necrotizing enterocolitis (NEC) differed between groups (all stages 3.9% DHM, 11.0% PTF; P = .01). Costs to 18 months did not differ with a mean (95% confidence interval) of 217 624 (197 697-237 551) and 217 245 (196 494-237 995) 2015 Canadian dollars in the DHM and PTF groups. Postdischarge costs were lower in the DHM (46 440 [40 648-52 233]) than PTF group (55 102 [48 269-61 934]) (P = .04), driven by parent lost wages. DHM cost an additional $5328 per case of averted NEC. CONCLUSIONS: In a high mother's milk use setting, total costs from a societal perspective to 18 months of providing supplemental DHM versus PTF to VLBW infants did not differ, although postdischarge costs were lower in the DHM group. Although supplemental DHM was not cost-saving, it reduced NEC supporting its use over PTF.

The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial.

BACKGROUND: Orally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure. METHODS: A total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups. RESULTS: There was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention. CONCLUSIONS: The minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02134873. Date: May 5, 2014 (retrospectively registered).

Neonatal Morbidity Count Is Associated With a Reduced Likelihood of Achieving Recommendations for Protein, Lipid, and Energy in Very Low Birth Weight Infants: A Prospective Cohort Study.

BACKGROUND: Serious morbidity may elevate nutrient requirements and affect adherence to feeding guidelines for very low birth weight (VLBW) infants. An understanding of factors affecting nutrient intakes of VLBW infants will facilitate development of strategies to improve nutrient provision. Our aim was to examine the impact of neonatal morbidity count on achieving recommended nutrient intakes in VLBW infants. METHODS: VLBW infants enrolled in the Donor Milk for Improved Neurodevelopmental Outcomes trial (ISRCTN35317141, n = 363) were included. Serious morbidities and daily parenteral and enteral intakes were collected prospectively. RESULTS: Median intakes of infants with and without ≥1 morbidity met protein recommendations (3.5-4.5 g/kg/d) by week 2, although not maintained after week 4. Infants with ≥1 morbidity (vs without) were 2 weeks slower in achieving lipid (4.8-6.6 g/kg/d; week 4 vs 2) and energy (110-130 kcal/kg/d; week 5 vs 3) and 1 week slower in achieving carbohydrate recommendations (11.6-13.2 g/kg/d; week 4 vs 3). Adjusted hazard ratios of first achieving recommendations on any given day in infants with any 1 or 2 morbidities were 0.6 (95% confidence interval [CI], 0.5-0.9) and 0.6 (0.4-0.9), respectively, for protein; 0.5 (0.4-0.7) and 0.3 (0.2-0.5) for lipid; and 0.5 (0.4-0.7) and 0.3 (0.2-0.4) for energy. CONCLUSION: Morbidity is associated with a decreased likelihood of achieving lipid and consequently energy recommendations. This and the decline in protein intakes after the early neonatal period require further investigation to ensure optimal nutrition in this vulnerable population.

How Close Are We to Achieving Energy and Nutrient Goals for Very Low Birth Weight Infants in the First Week?

BACKGROUND: Emerging evidence suggests intakes of protein and energy as early as the first week of life in preterm very low birth weight (VLBW) infants are associated with improved neurodevelopment. In response, many neonatal intensive care units (NICUs) have launched new, more aggressive early feeding guidelines. The aim of this study was to evaluate enteral and parenteral energy and macronutrient intakes during the first postnatal week in VLBW infants admitted to NICUs that have introduced more aggressive early feeding guidelines. MATERIALS AND METHODS: Estimated energy and macronutrient intakes were prospectively collected from VLBW infants fed exclusively mother's own milk and/or parenteral nutrition and compared with expert recommendations. Days to reach full enteral feeds (150 mL/kg/d) and discharge anthropometrics were examined. RESULTS: By days 6 and 7, median protein and lipid intakes, respectively, reached recommended values (3.5 and 3.0 g/kg/d). However, by day 8, many infants remained below recommended intakes for protein (34%), lipid (34%), carbohydrate (68%), and energy (71%). Late-onset sepsis was associated with a decreased likelihood of reaching full enteral feeds on any given day (hazard ratio, 0.2; 95% confidence interval, 0.1-0.5; P ≤ .0009). There was no significant relationship between week 1 nutrient intakes and anthropometrics at discharge. CONCLUSION: Despite the introduction of more aggressive early feeding guidelines and improved energy and nutrient intakes compared with literature values, many VLBW infants remain below recommended nutrition goals in the first week.

Partners in research: building academic-practice partnerships to educate and mentor advanced practice nurses.

RATIONALE: Clinical practice is the primary focus of advanced practice nursing (APN) roles. However, with unprecedented needs for health care reform and quality improvement (QI), health care administrators are seeking new ways to utilize all dimensions of APN expertise, especially related to research and evidence-based practice. International studies reveal research as the most underdeveloped and underutilized aspect of these roles. AIMS: To improve patient care by strengthening the capacity of advanced practice nurses to integrate research and evidence-based practice activities into their day-to-day practice. METHODS: An academic-practice partnership was created among hospital-based advanced practice nurses, nurse administrators, and APN researchers to create an innovative approach to educate and mentor advanced practice nurses in conducting point-of-care research, QI, or evidence-based practice projects to improve patient, provider, and/or system outcomes. A practice-based research course was delivered to 2 cohorts of advanced practice nurses using a range of teaching strategies including 1-to-1 academic mentorship. All participants completed self-report surveys before and after course delivery. RESULTS: Through participation in this initiative, advanced practice nurses enhanced their knowledge, skills, and confidence in the design, implementation, and/or evaluation of research, QI, and evidence-based practice activities. CONCLUSION: Evaluation of this initiative provides evidence of the acceptability and feasibility of academic-practice partnerships to educate and mentor point-of-care providers on how to lead, implement, and integrate research, QI and evidence-based activities into their practices.

Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: A Randomized Clinical Trial.

Importance: For many very low-birth-weight (VLBW) infants, there is insufficient mother's milk, and a supplement of pasteurized donor human milk or preterm formula is required. Awareness of the benefits of mother's milk has led to an increase in use of donor milk, despite limited data evaluating its efficacy. Objective: To determine if nutrient-enriched donor milk compared with formula, as a supplement to mother's milk, reduces neonatal morbidity, supports growth, and improves neurodevelopment in VLBW infants. Design, Setting, and Participants: In this pragmatic, double-blind, randomized trial, VLBW infants were recruited from 4 neonatal units in Ontario, Canada, within 96 hours of birth between October 2010 and December 2012. Follow-up was completed in July 2015. Interventions: Infants were fed either donor milk or formula for 90 days or to discharge when mother's milk was unavailable. Main Outcomes and Measures: The primary outcome was the cognitive composite score on the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) at 18 months' corrected age (standardized mean, 100 [SD, 15]; minimal clinically important difference, 5 points). Secondary outcomes included Bayley-III language and motor composite scores, growth, and a dichotomous mortality and morbidity index. Results: Of 840 eligible infants, 363 (43.2%) were randomized (181 to donor milk and 182 to preterm formula); of survivors, 299 (92%) had neurodevelopment assessed. Mean birth weight and gestational age of infants was 996 (SD, 272) g and 27.7 (2.6) weeks, respectively, and 195 (53.7%) were male. No statistically significant differences in mean Bayley-III cognitive composite score (adjusted scores, 92.9 in donor milk group vs 94.5 in formula group; fully adjusted mean difference, -2.0 [95% CI, -5.8 to 1.8]), language composite score (adjusted scores, 87.3 in donor milk group vs 90.3 in formula group; fully adjusted mean difference, -3.1 [95% CI, -7.5 to 1.3]), or motor composite score (adjusted scores, 91.8 in donor milk group vs 94.0 in formula group; fully adjusted mean difference, -3.7 [95% CI, -7.4 to 0.09]) were observed between groups. There was no statistically significant difference in infants positive for the mortality and morbidity index (43% in donor milk group, 40% in formula group) or changes in growth z scores. Conclusions and Relevance: Among VLBW infants, use of supplemental donor milk compared with formula did not improve neurodevelopment at 18 months' corrected age. If donor milk is used in settings with high provision of mother's milk, this outcome should not be considered a treatment goal. Trial Registration: isrctn.org Identifier: ISRCTN35317141.

Pain and distress caused by endotracheal suctioning in neonates is better quantified by behavioural than physiological items: a comparison based on item response theory modelling.

Pain cannot be directly measured in neonates. Therefore, scores based on indirect behavioural signals such as crying, or physiological signs such as blood pressure, are used to quantify neonatal pain both in clinical practice and in clinical studies. The aim of this study was to determine which of the physiological and behavioural items of 2 validated pain assessment scales (COMFORT and premature infant pain profile) are best able to detect pain during endotracheal and nasal suctioning in ventilated newborns. We analysed a total of 516 PIPP and COMFORT scores from 118 newborns. A graded response model was built to describe the data and item information was calculated for each of the behavioural and physiological items. We found that the graded response model was able to well describe the data, as judged by agreement between the observed data and model simulations. Furthermore, a good agreement was found between the pain estimated by the graded response model and the investigator-assessed visual analogue scale scores (Spearman rho correlation coefficient = 0.80). The information scores for the behavioural items ranged from 1.4 to 27.2 and from 0.0282 to 0.131 for physiological items. In these data with mild to moderate pain levels, behavioural items were vastly more informative of pain and distress than were physiological items. The items that were the most informative of pain are COMFORT items "calmness/agitation," "alertness," and "facial tension."

Perceptions of health professionals on pain in extremely low gestational age infants.

Extremely low gestational age infants (<28 weeks at birth) experience significant pain from repeated therapeutic procedures while hospitalized in the neonatal intensive care unit. As part of a program of research examining pain in preterm infants, we conducted a qualitatively driven mixed-methods design, supplemented with a qualitative and quantitative component, to understand how health care professionals (HCPs) assess and manage procedural pain for tiny and underdeveloped preterm infants. Fifty-nine HCPs from different disciplines across four tertiary-level neonatal units in Canada participated in individual or focus group interviews and completed a brief questionnaire. Four themes from the content analysis were (a) subtlety and unpredictability of pain indicators, (b) infant and caregiver attributes and contextual factors that influence pain response and practices, (c) the complex nature of pain assessment, and (d) uncertainty in the management of pain. The information gleaned from this study can assist in identifying gaps in knowledge and informing unit-based and organizational knowledge translation strategies for this vulnerable population.

DoMINO: Donor milk for improved neurodevelopmental outcomes.

BACKGROUND: Provision of mother's own milk is the optimal way to feed infants, including very low birth weight infants (VLBW, <1500 g). Importantly for VLBW infants, who are at elevated risk of neurologic sequelae, mother's own milk has been shown to enhance neurocognitive development. Unfortunately, the majority of mothers of VLBW infants are unable to provide an adequate supply of milk and thus supplementation with formula or donor milk is necessary. Given the association between mother's own milk and neurodevelopment, it is important to ascertain whether provision of human donor milk as a supplement may yield superior neurodevelopmental outcomes compared to formula.Our primary hypothesis is that VLBW infants fed pasteurized donor milk compared to preterm formula as a supplement to mother's own milk for 90 days or until hospital discharge, whichever comes first, will have an improved cognitive outcome as measured at 18 months corrected age on the Bayley Scales of Infant Development, 3(rd) ed. Secondary hypotheses are that the use of pasteurized donor milk will: (1) reduce a composite of death and serious morbidity; (2) support growth; and (3) improve language and motor development. Exploratory research questions include: Will use of pasteurized donor milk: (1) influence feeding tolerance and nutrient intake (2) have an acceptable cost effectiveness from a comprehensive societal perspective? METHODS/DESIGN: DoMINO is a multi-centre, intent-to-treat, double blinded, randomized control trial. VLBW infants (n = 363) were randomized within four days of birth to either (1) pasteurized donor milk or (2) preterm formula whenever mother's own milk was unavailable. Study recruitment began in October 2010 and was completed in December 2012. The 90 day feeding intervention is complete and long-term follow-up is underway. DISCUSSION: Preterm birth and its complications are a leading cause long-term morbidity among Canadian children. Strategies to mitigate this risk are urgently required. As mother's own milk has been shown to improve neurodevelopment, it is essential to ascertain whether pasteurized donor milk will confer the same advantage over formula without undue risks and at acceptable costs. Knowledge translation from this trial will be pivotal in setting donor milk policy in Canada and beyond. TRIAL REGISTRATION: ISRCTN35317141; Registered 10 August 2010.

Improvements in staff quality of work life and family satisfaction following the move to single-family room NICU design.

OBJECTIVE: The purpose of this study was to determine whether there were differences in staff quality of work life and parent satisfaction when a neonatal intensive care unit moved from an open-bay design to a single-room model of care. DESIGN: This descriptive study measured staff quality of work life and family satisfaction before and at 2 time periods after the relocation of a perinatal centre and the introduction of single-family room care. Differences in work life quality and satisfaction were determined using 2-sample t-tests. RESULT: There were improvements in staff quality of work life and family satisfaction at both time periods following the move. CONCLUSION: Lessons learned may be of value to other units considering such a move. A neonatal intensive care unit designed to contribute to parental and staff well-being is a model to be considered for future neonatal designs.

Validation of the Premature Infant Pain Profile-Revised (PIPP-R).

OBJECTIVES: To examine the construct validity, inter-rater reliability, and feasibility of the Premature Infant Pain Profile-Revised in infants of varying gestational ages, diagnoses, and procedures. METHODS: A prospective cross-over study with infants in three gestational age groups (26-31, 32-36, and ≥37 weeks) at three university-affiliated Neonatal Intensive Care Units in Canada. One hundred and ninety five bedside nurses and expert raters rated 202 hospitalized infants' pain during scheduled procedures using the measure. An expert rater and a nurse independently assessed infants' pain scores, using the Premature Infant Pain Profile-Revised, during 246 scheduled pairs of painful and non-painful procedures in the 202 infants. Nurses also completed a feasibility survey on using the measure in a clinical setting. To establish construct validity, pain scores were computed during painful and non-painful procedures. Inter-rater reliability between pain experts and nurses was calculated. A 5-point Likert scale was used to measure feasibility in terms of clarity, ease of use, and time to complete. RESULTS: Irrespective of gestational age, Premature Infant Pain Profile-Revised scores were significantly higher during painful procedures (mean 6.7 [SD 3.0]) compared to non-painful procedures (mean 4.8 [SD 2.9]). There was a high degree of correlation between nurses' and experts' ratings for painful (all R(2)=0.92, p<0.001) and non-painful (all R(2)=0.87, p<0.001) procedures. Mean scores on all feasibility indicators were equal to or higher than 3.8. DISCUSSION: The Premature Infant Pain Profile Revised has beginning construct validation, inter-rater reliability, and is considered feasible by clinicians. Concurrent validation studies should be considered.

The premature infant pain profile-revised (PIPP-R): initial validation and feasibility.

OBJECTIVES: To describe revisions to the Premature Infant Pain Profile (PIPP) and initial construct validation and feasibility of the Premature Infant Pain Profile-Revised (PIPP-R). METHODS: The PIPP was revised to enhance validity and feasibility. To validate the PIPP-R, data from 2 randomized cross-over studies were utilized to: (1) calculate and compare PIPP and PIPP-R scores in extremely low gestational age infants undergoing a painful and nonpainful event (N=52; dataset #1) and (2) calculate and compare PIPP and PIPP-R scores in assessing the effectiveness of (a) sucrose, (b) non-nutritive sucking (NNS)+sucrose, and (c) facilitated tucking+NNS+sucrose during heel lance (N = 85; dataset #2). Pearson correlations between PIPP and PIPP-R scores were calculated, and Student t tests and 1-way analysis of variance were used to determine construct validity during painful and nonpainful events. To establish feasibility, a survey of 31 Neonatal Intensive Care Unit nurses was conducted. RESULTS: PIPP-R scores were significantly lower during nonpainful (mean, 8.3; SD = 2.9) compared with painful (mean, 9.9; SD=3.1; t95 = 4.51, P = 0.036) events in extremely low gestational age infants in dataset #1. In dataset #2, PIPP-R scores were significantly lower in infants 25 to 41 weeks gestation in the group receiving NNS+sucrose compared with the other 2 groups (F2,79 = 2.9, P<0.05). Overall, nurses rated the PIPP-R as feasible. DISCUSSION: Initial construct validation and feasibility of the PIPP-R was demonstrated. Further testing with infants of varying gestational ages, diagnoses, and pain conditions is required; as is exploration of PIPP-R in relation to other types of physiological and cognitive responses.

Alternative female kangaroo care for procedural pain in preterm neonates: a pilot study.

AIM: To determine the feasibility and effect size of kangaroo care (KC) for pain from heel lance in preterm neonates provided by either the infant's mother (MKC) or an unrelated alternate female (AFKC). METHODS: Using a randomized crossover design, preterm neonates (n = 18) between 28 and 37 weeks gestational age within 10 days of life from two university-affiliated level III NICU's undergoing routine heel lance were assigned to receive KC 30 min before and during the procedure from either their mother (MKC) or an unrelated woman. In the second heel lance procedure at least 24 h later but within 10 days, the infants were crossed over to the other condition. RESULTS: There was a 48% participation rate, with only 40 of 82 eligible cases having maternal consent. The main reason for refusal was discomfort with another woman providing kangaroo care. The effect sizes on the pain scores (PIPP) were small, ranging from .23 to .43 across the first 2 min of procedure. CONCLUSION: The difference between nonrelated females and the mother in decreasing pain response is small, although not negligible. Given the high refusal rate, nonrelated females are a less desirable alternative to mothers than fathers.

The influence of context on pain practices in the NICU: perceptions of health care professionals.

In this qualitative descriptive study, we explored health care professionals' perceptions of the influence of context (i.e., organizational culture, structure, resources, capabilities/competencies, and politics) on evidence-based pain practices. A total of 16 focus groups with 147 health care professionals were conducted in three neonatal intensive care units (NICUs) in central and eastern Canada. Three overarching themes emerged from the data, which captured influences on optimal pain practices in the NICU, including (a) a culture of collaboration and support for evidence-based practice, (b) threats to autonomous decision making, and (c) complexities in care delivery. These results were consistent with theoretical conceptualizations of how context influences practice, as well as recent empirical research findings. This study supports the importance of context in shaping evidence-based practices by health care professionals in the management of pain in the NICU.

The premature infant pain profile: evaluation 13 years after development.

OBJECTIVE: To review the (1) reliability, validation, feasibility, and clinical utility and (2) the use of the Premature Infant Pain Profile (PIPP) from 1996 to 2009 to determine the effectiveness of pain management strategies. METHODS: Data sources included MEDLINE, CINAHL, EMBASE, PsycINFO, and the Web of Science. Published studies evaluating the measurement properties of the PIPP and intervention studies using the PIPP as an outcome measure of acute pain were included. One reviewer screened studies for relevance and inclusion. Four reviewers rated intervention studies for methodological quality and extracted data for the evidence tables. RESULTS: Of the 62 studies included, 14 focused on the measurement properties of the PIPP. Reliability of the PIPP was supported in 5 studies and construct validation was supported in 13 studies. The feasibility of the PIPP was addressed in 4 studies, whereas clinical utility was discussed in 2 studies. Twenty-seven of the 48 studies that were considered to have high methodological quality used the PIPP as the major outcome to evaluate the effectiveness of pain management interventions in infants. DISCUSSION: The PIPP continues to be a reliable and valid measure of acute pain in infants with numerous positive validation studies. There is substantial support for the use of the PIPP as an effective outcome measure in pain intervention studies in infants. Further research with health professionals is required to better support the feasibility and clinical utility of this measure.