Pre-phototherapy total serum bilirubin levels in extremely preterm infants.

BACKGROUND: Extremely preterm infants are prone to hyperbilirubinemia and its sequelae. Currently recommended thresholds for initiating phototherapy in these newborns are consensus-based (CB). METHODS: A multi-site retrospective cohort study of 642 infants born at 240/7 to 286/7 weeks' gestation, between January 2013 and June 2017, was conducted at three NICUs in Canada. Pre-phototherapy TSB percentile levels at 24 h of age were generated and contrasted with published CB thresholds. RESULTS: Among infants born 240/7 to 256/7 weeks' gestation, the differences between our TSB percentiles vs. the CB threshold of 85.0 µmol/L were 10.0 µmol/L (95% CI, 6.0-16.0) at the 75th percentile and 35.3 µmol/L (95% CI, 26.1-42.8) at the 95th percentile. Respectively, among infants born at 260/7 to 276/7 weeks, differences were 19.4 µmol/L (95% CI, 16.8-23.4) and 43.3 µmol/L (95% CI, 34.7-46.9). Born at 280/7 to 286/7 weeks' gestation, differences between our 75th and 95th TSB percentiles and the CB threshold of 103 µmol/L were 6.9 µmol/L (95% CI, 3.2-12.0) and 36.0 µmol/L (95% CI, 31.0-44.3), respectively. CONCLUSIONS: We provide statistically derived pre-phototherapy TSB levels that may clarify patterns of pre-phototherapy TSB levels in extremely preterm infants. IMPACT: We present statistically derived pre-phototherapy total serum bilirubin levels in a cohort of extremely preterm infants. Most of these preterm infants received phototherapy-some at below currently published thresholds. There are notable differences between our statistically derived pre-phototherapy TSB levels and currently published lower limit TSB thresholds for phototherapy. Our study results assist in the understanding of pre-phototherapy TSB levels in extremely preterm infants.

Fathers' Experiences in Alberta Family Integrated Care: A Qualitative Study.

BACKGROUND: The Family Integrated Care (FICare) program adapted for Alberta (AB) level II neonatal intensive care units (NICUs) aims to increase parental involvement and support during their NICU stay. The experience of fathers of preterm infants in a FICare program is currently unknown. PURPOSE: To describe the experiences of fathers of preterm infants born at 320/7 to 346/7 weeks' gestational age with AB FICare. METHODS: A qualitative substudy of a multicenter prospective cluster randomized controlled trial of FICare in 10 level II NICUs across Alberta. Fathers of preterm infants participated in a semistructured interview after discharge when their infants were at least 2 months' corrected gestational age. Journal entries written by fathers while in the NICU from the FICare intervention sites were also collected. Data were analyzed thematically and the interview and journal data were triangulated. FINDINGS: Thirteen fathers (9 from the FICare intervention and 4 from standard care) participated in semistructured interviews and there were 24 journals collected. Seven themes emerged: fear of the unknown, mental preparation, identifying the father's role, parenting with supervision, effective communication, postneonatal intensive care transition, and family life. Fathers enrolled in AB FICare attributed their level of confidence and positive neonatal intensive care experience that continued postdischarge to the care and attention they received during hospitalization. CONCLUSION: AB FICare may improve experiences for fathers of preterm infants in the NICU with continuation postdischarge. Future research should include designing and evaluating father-specific NICU programs.

Hour-Specific Total Serum Bilirubin Percentiles for Infants Born at 29-35 Weeks' Gestation.

INTRODUCTION: As preterm infants are susceptible to hyperbilirubinemia, they require frequent close monitoring. Prior to initiation of phototherapy, hour-specific total serum bilirubin (TSB) percentile cut-points are lacking in these infants, which led to the current study. METHODS: A multi-site retrospective cohort study of preterm infants born between January 2013 and June 2017 was completed at 3 NICUs in Ontario, Canada. A total of 2,549 infants born at 290/7-356/7 weeks' gestation contributed 6,143 pre-treatment TSB levels. Hour-specific TSB percentiles were generated using quantile regression, further described by degree of prematurity, and among those who subsequently received phototherapy. RESULTS: Among all infants, at birth, hour-specific pre-treatment, TSB percentiles were 36.1 µmol/L (95% confidence interval [CI]: 34.3-39.3) at the 40th, 52.3 µmol/L (49.4-55.1) at the 75th, and 79.5 µmol/L (72.1-89.6) at the 95th percentiles. The corresponding percentiles were 39.3 µmol/L (35.9-43.2), 55.4 µmol/L (52.1-60.2), and 87.1 µmol/L (CI 70.5-102.4) prior to initiating phototherapy and 24.4 µmol/L (20.4-28.8), 35.3 µmol/L (31.1-41.5), and 52.0 µmol/L (46.1-62.4) among those who did not receive phototherapy. Among infants born at 29-32 weeks, pre-treatment TSB percentiles were 53.9 µmol/L (49.4-61.0) and 95.5 µmol/L (77.5-105.0) at the 75th and 95th percentiles, with respective values of 48.7 µmol/L (43.0-52.3), and 74.1 µmol/L (64.8-83.2) for those born at 33-35 weeks' gestation. CONCLUSION: Hour-specific TSB percentiles, derived from a novel nomogram, may inform how bilirubin is described in preterm newborns. Further research of pre-treatment TSB levels is required before clinical consideration.

Transcutaneous versus Total Serum Bilirubin Measurements in Preterm Infants.

INTRODUCTION: Transcutaneous bilirubin (TcB) measurement offers a noninvasive approach for bilirubin screening; however, its accuracy in preterm infants is unclear. This study determined the agreement between TcB and total serum bilirubin (TSB) among preterm infants. METHODS: A multisite prospective cohort study was conducted at 3 NICUs in Ontario, Canada, September 2016 to June 2018. Among 296 preterm infants born at 240/7 to 356/7 weeks, 856 TcB levels were taken at the forehead, sternum, and before and after the initiation of phototherapy with TSB measurements. Bland-Altman plots and 95% limits of agreement (LOA) expressed agreement between TcB and TSB. RESULTS: The overall mean TcB-TSB difference was -24.5 µmol/L (95% LOA -103.3 to 54.3), 1.6 µmol/L (95% LOA -73.4 to 76.5) before phototherapy, and -31.1 µmol/L (95% LOA -105.5 to 43.4) after the initiation of phototherapy. The overall mean TcB-TSB difference was -15.2 µmol/L (95% LOA -86.8 to 56.3) at the forehead and -24.4 µmol/L (95% LOA -112.9 to 64.0) at the sternum. The mean TcB-TSB difference was -31.4 µmol/L (95% LOA -95.3 to 32.4) among infants born 24-28 weeks, -25.5 µmol/L (95% LOA -102.7 to 51.8) at 29-32 weeks, and -15.9 µmol/L (95% LOA -107.4 to 75.6) at 33-35 weeks. Measures did not differ by maternal ethnicity. CONCLUSION: Among preterm infants, TcB may offer a noninvasive, immediate approach to screening for hyperbilirubinemia with more careful use in preterm infants born at <33 weeks' gestation, as TcB approaches treatment thresholds. Its underestimation of TSB after the initiation of phototherapy warrants the use of TSB for clinical decision-making after the initiation of phototherapy.

Effectiveness of oral intake of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 on Group B Streptococcus colonization during pregnancy: a midwifery-led double-blind randomized controlled pilot trial.

OBJECTIVE: Group B streptococcus (GBS) vaginal/rectal colonization in pregnancy has been associated with early-onset GBS disease (EOGBSD), a leading cause of neonatal morbidity and mortality. In Canada, universal screening for GBS colonization is offered to pregnant people at 35-37 weeks' gestation and those who test positive are offered intrapartum antibiotic prophylaxis (IAP). Universal screening and treatment with IAP have not eradicated all cases of EOGBSD, and IAP has documented side effects. Probiotic supplements have been proposed as a possible way to reduce GBS colonization. MATERIALS AND METHODS: Pregnant midwifery clients >18 years of age and <45 years of age and with a gestational age of <25 weeks at the time of enrolment were randomly assigned to receive two capsules of probiotics (Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) or placebo orally daily for 12 weeks at 23-25 weeks' gestation. The primary aim was to determine the feasibility of a larger study. The rate of GBS vaginal/rectal colonization at 35-37 weeks' gestation was also assessed in both groups. RESULTS: In total, 139 pregnant midwifery clients were randomized (probiotic group [N = 73] and placebo group [N = 66]). Of these, 113 were included in the final analysis (probiotic group [N = 57] and placebo group [N = 56]). Baseline characteristics between groups were similar with the exception of gestational age (p < .01). The recruitment rate was low at 12%, but the mean compliance rate was 87%. The eligibility/ineligibility criteria were too strict and changes to the study design will be required for the larger proposed study. The rates of vaginal/rectal GBS colonization did not differ significantly between groups (15.8 versus 21.43%; p = .48). No adverse effects were documented in the probiotic group. CONCLUSION: This was the first midwifery-led trial involving a natural health product in the province of Ontario. Although treatment with oral probiotics is feasible, the results were not superior to placebo in reducing the rate of GBS colonization. An adequately powered, randomly controlled trial is required to assess the effectiveness of the two probiotic strains.

Effectiveness of Alberta Family Integrated Care on infant length of stay in level II neonatal intensive care units: a cluster randomized controlled trial.

BACKGROUND: Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. METHODS: In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. RESULTS: We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, - 4.44 to - 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups. CONCLUSIONS: Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.

The health care system is making 'too much noise' to provide family-centred care in neonatal intensive care units: Perspectives of health care providers and hospital administrators.

AIM: To describe the perspectives of health care providers and hospital administrators on their experiences of providing care for infants in Level II neonatal intensive care units and their families. RESEARCH METHODS: We conducted 36 qualitative interviews with neonatal health care providers and hospital administrators and analysed data using a descriptive interpretive approach. SETTING: 10 Level II Neonatal Intensive Care Units in a single, integrated health care system in one Canadian province. FINDINGS: Three major themes emerged: (1) providing family-centred care, (2) working amidst health care system challenges, and (3) recommending improvements to the health care system. The overarching theme was that the health care system was making 'too much noise' for health care providers and hospital administrators to provide family-centred care in ways that would benefit infants and their families. Recommended improvements included: refining staffing models, enhancing professional development, providing tools to deliver consistent care, recognising parental capacity to be involved in care, strengthening continuity of care, supporting families to be with their infant, and designing family-friendly environments. CONCLUSION: When implementing family-centred care initiatives, health care providers and hospital administrators need to consider the complexity of providing care in Level II Neonatal Intensive Care Units, and recognise that health care system changes may be necessary to optimise implementation.

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

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.

Arginine supplementation for prevention of necrotising enterocolitis in preterm infants.

BACKGROUND: Decreased concentration of nitric oxide has been proposed as one of the possible cellular mechanisms of necrotising enterocolitis (NEC). Arginine can act as a substrate for production of nitric oxide in the tissues, and arginine supplementation may help to prevent NEC. OBJECTIVES: To examine the effect of arginine supplementation (administered by any route) on the incidence of NEC in preterm neonates. To conduct subgroup analyses based on the dose of arginine and the gestational age of participants (≤ 32 weeks, > 32 weeks). SEARCH METHODS: We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 4), MEDLINE via PubMed (from 1966 to 12 May 2016), Embase (from 1980 to 12 May 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; from 1982 to 12 May 2016). We also searched clinical trials databases, conference proceedings and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of arginine supplementation (administered orally or parenterally for at least seven days, in addition to what an infant may be receiving from an enteral or parenteral source) compared with placebo or no treatment. DATA COLLECTION AND ANALYSIS: We assessed the methodological quality of trials by using information obtained from study reports and through personal communication with study authors. We extracted data on relevant outcomes and estimated and reported the effect size as risk ratio (RR), risk difference (RD) and mean difference (MD), as appropriate. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of evidence. MAIN RESULTS: We identified three eligible studies that included a total of 285 neonates (140 received arginine) from three countries. We assessed the overall methodological quality of the included studies as good. We noted a statistically significant reduction in risk of development of NEC (any stage) among preterm neonates in the arginine group compared with the placebo group (RR 0.38, 95% confidence interval (CI) 0.23 to 0.64; I2 = 27%) (RD -0.19, 95% CI -0.28 to -0.10; I2 = 0%) and rated the quality of evidence as moderate. The number needed to treat for an additional beneficial outcome (NNTB) as required to prevent the development of NEC (any stage) was 6 (95% CI 4 to 10). Study results showed a statistically significant reduction in risk of development of NEC stage 1 (RR 0.37, 95% CI 0.15 to 0.90; I2 = 52%) (RD -0.07, 95% CI -0.14 to -0.01; I2 = 0%) and NEC stage 3 (RR 0.13, 95% CI 0.02 to 1.03; I2 = 0%) (RD -0.05, 95% CI -0.09 to -0.01; I2 = 89%) in the arginine group compared with the control group; the quality of evidence was moderate.Arginine supplementation was associated with a significant reduction in death related to NEC (RR 0.18, 95% CI 0.03 to 1.00; I2 = 0%) (RD -0.05, 95% CI -0.09 to -0.01; I2 = 87%). Results showed clinical heterogeneity in mortality rates. Mortality due to any cause was not significantly different between arginine and control or no treatment groups (RR 0.77, 95% CI 0.41 to 1.45; I2 = 42%) (RD -0.03, 95% CI -0.10 to 0.04; I2 = 79%). Investigators noted no significant side effects directly attributable to arginine, including hypotension or alterations in glucose homeostasis. Follow-up data from one trial revealed no statistically significant differences in adverse outcomes (cerebral palsy, cognitive delay, bilateral blindness or hearing loss requiring hearing aids) at 36 months. Limitations of the present findings include a relatively small overall sample size. AUTHORS' CONCLUSIONS: Administration of arginine to preterm infants may prevent development of NEC. Because information was provided by three small trials that included 285 participants, the data are insufficient at present to support a practice recommendation. A multi-centre randomised controlled study that is focused on the incidence of NEC, particularly at more severe stages (2 and 3), is needed.

Breastfeeding for procedural pain in infants beyond the neonatal period.

BACKGROUND: Randomised controlled trials (RCTs) show that breastfeeding newborn infants during painful procedures reduces pain. Mechanisms are considered to be multifactorial and include sucking, skin-to-skin contact, warmth, rocking, sound and smell of the mother, and possibly endogenous opiates present in the breast milk. OBJECTIVES: To determine the effect of breastfeeding on procedural pain in infants beyond the neonatal period (first 28 days of life) up to one year of age compared to no intervention, placebo, parental holding, skin-to-skin contact, expressed breast milk, formula milk, bottle feeding, sweet-tasting solutions (e.g. sucrose or glucose), distraction, or other interventions. SEARCH METHODS: We searched the following databases to 18 February 2016: the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE including In-Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (apps.who.int/trialsearch/) for ongoing trials. SELECTION CRITERIA: We included RCTs and quasi-RCTs involving infants aged 28 days postnatal to 12 months and receiving breastfeeding while undergoing a painful procedure. Comparators included, but were not limited to, oral administration of water, sweet-tasting solutions, expressed breast or formula milk, no intervention, use of pacifiers, positioning, cuddling, distraction, topical anaesthetics, and skin-to-skin care. Procedures included, but were not limited to: subcutaneous or intramuscular injection, venipuncture, intravenous line insertion, heel lance, and finger lance. We applied no language restrictions. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data. The main outcome measures were behavioural or physiological indicators and composite pain scores, as well as other clinically important outcomes reported by the authors of included studies. We pooled data for the most comparable outcomes and where data from at least two studies could be included. We used mean difference (MD) with 95% confidence interval (CI), employing a random-effects model for continuous outcomes measured on the same scales. For continuous outcomes measured on different scales, we pooled standardised mean differences (SMDs) and associated 95% CIs. For dichotomous outcomes, we planned to pool events between groups across studies using risk ratios (RRs) and 95% CIs. However, as insufficient studies reported dichotomous outcomes, we did not pool such events. We assessed the evidence using GRADE and created a 'Summary of findings' table. MAIN RESULTS: We included 10 studies with a total of 1066 infants. All studies were conducted during early childhood immunisation. As the breastfeeding intervention cannot be blinded, we rated all studies as being at high risk of bias for blinding of participants and personnel. We assessed nine studies as being at low risk of bias for incomplete outcome data. In addition, we rated nine studies as high risk for blinding of outcome assessment. We scored risk of bias related to random sequence generation, allocation concealment, and selective reporting as unclear for the majority of the studies due to lack of information.Our primary outcome was pain. Breastfeeding reduced behavioural pain responses (cry time and pain scores) during vaccination compared to no treatment, oral water, and other interventions such as cuddling, oral glucose, topical anaesthetic, massage, and vapocoolant. Breastfeeding did not consistently reduce changes in physiological indicators, such as heart rate. We pooled data for duration of cry from six studies (n = 547 infants). Breastfeeding compared to water or no treatment resulted in a 38-second reduction in cry time (MD -38, 95% CI -50 to -26; P < 0.00001). The quality of the evidence according to GRADE for this outcome was moderate, as most infants were 6 months or younger, and outcomes may be different for infants during their 12-month immunisation. We pooled data for pain scores from five studies (n = 310 infants). Breastfeeding was associated with a 1.7-point reduction in standardised pain scores (SMD -1.7, 95% CI -2.2 to -1.3); we considered this evidence to be of moderate quality as data were primarily from infants younger than 6 months of age. We could pool heart rate data following injections for only two studies (n = 186); we considered this evidence to be of low quality due to insufficient data. There were no differences between breastfeeding and control (MD -3.6, -23 to 16).Four of the 10 studies had more than two study arms. Breastfeeding was more effective in reducing crying duration or pain scores during vaccination compared to: 25% dextrose and topical anaesthetic cream (EMLA), vapocoolant, maternal cuddling, and massage.No included studies reported adverse events. AUTHORS' CONCLUSIONS: We conclude, based on the 10 studies included in this review, that breastfeeding may help reduce pain during vaccination for infants beyond the neonatal period. Breastfeeding consistently reduced behavioural responses of cry duration and composite pain scores during and following vaccinations. However, there was no evidence that breastfeeding had an effect on physiological responses. No studies included in this review involved populations of hospitalised infants undergoing other skin-breaking procedures. Although it may be possible to extrapolate the review results to this population, further studies of efficacy, feasibility, and acceptability in this population are warranted.

Glycerin laxatives for prevention or treatment of feeding intolerance in very low birth weight infants.

BACKGROUND: Feeding intolerance is a common clinical problem among preterm infants. It may be an early sign of necrotising enterocolitis, sepsis or other serious gastrointestinal conditions, or it may result from gut immaturity with delayed passage of meconium. Glycerin laxatives stimulate passage of meconium by acting as an osmotic dehydrating agent and increasing osmotic pressure in the gut; they stimulate rectal contraction, potentially reducing the incidence of feeding intolerance. OBJECTIVES: To assess the effectiveness and safety of glycerin laxatives (enemas/suppositories) for prevention or treatment of feeding intolerance in very low birth weight (VLBW) infants. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 4), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We restricted our search to all randomised controlled trials and applied no language restrictions. We searched the references of identified studies and reviews on this topic and handsearched for additional articles. We searched the database maintained by the US National Institutes of Health (www.clinicaltrials.gov) and European trial registries to identify ongoing trials. SELECTION CRITERIA: We considered only randomised or quasi-randomised controlled trials that enrolled preterm infants < 32 weeks' gestational age (GA) and/or < 1500 g birth weight. We included trials if they administered glycerin laxatives and measured at least one prespecified clinical outcome. DATA COLLECTION AND ANALYSIS: We used standard methods of The Cochrane Collaboration and its Neonatal Group to assess methodological quality of trials, to collect data and to perform analyses. MAIN RESULTS: We identified three trials that evaluated use of prophylactic glycerin laxatives in preterm infants. We identified no trials that evaluated therapeutic use of glycerin laxatives for feeding intolerance. Our review showed that prophylactic administration of glycerin laxatives did not reduce the time required to achieve full enteral feeds and did not influence secondary outcomes, including duration of hospital stay, mortality and weight at discharge. Prophylactic administration of glycerin laxatives resulted in failure of fewer infants to pass stool over the first 48 hours. Included trials reported no adverse events. AUTHORS' CONCLUSIONS: Our review of available evidence for glycerin laxatives does not support the routine use of prophylactic glycerin laxatives in clinical practice. Additional studies are needed to confirm or refute the effectiveness and safety of glycerin laxatives for prevention or treatment of feeding intolerance in VLBW infants.

A single preoperative dose of gabapentin does not improve postcesarean delivery pain management: a randomized, double-blind, placebo-controlled dose-finding trial.

BACKGROUND: A single preoperative dose of 600 mg gabapentin, combined with multimodal analgesia, has previously been shown to reduce postcesarean pain and improve maternal satisfaction but was associated with increased maternal sedation. We hypothesized that a lower dose of gabapentin may be effective with less sedation. METHODS: We conducted a doubleblind, randomized, placebo-controlled study. Women undergoing elective cesarean delivery were randomized into 3 groups to receive 300 or 600 mg oral gabapentin, or placebo, 1 hour before surgery. Temporal summation (TS) testing was performed at the time of study drug administration, and a visual analog scale (0 to 100 mm) difference ≥10 mm between the 1st and 10th stimuli was considered TS+. Spinal anesthesia and postoperative analgesia were instituted, including intrathecal fentanyl and morphine, oral diclofenac and acetaminophen, and systemic morphine as required. Pain assessments at rest and on movement (visual analog scale 0 to 100 mm) were conducted at 6, 12, 24, and 48 hours after surgical incision. The primary outcome was pain on movement at 24 hours. Secondary outcomes included satisfaction with analgesia, supplemental opioid consumption, lactation difficulties, neonatal outcomes, maternal sedation, and other adverse effects. Three months after delivery, patients were contacted for assessment of chronic pain. RESULTS: One hundred thirty-two women were randomized and 6 were excluded. The difference in mean pain scores at 24 hours (95% confidence intervals [CI]) were as follows: 600 mg versus 300 mg mean difference: 5 mm (95% adjusted CI, -7 to 17); 600 mg versus placebo: 3 mm (-9 to 15); 300 mg versus placebo: -2 mm [-14 to 10]; overall P value = 0.61. There was no apparent benefit of gabapentin in TS+ women, although overall pain scores were significantly higher in these women irrespective of the study group. CONCLUSION: Given the wide confidence intervals of the differences in mean pain scores, the current study did not allow us to determine whether a single preoperative dose of gabapentin (300 mg and 600 mg) improved postcesarean analgesia compared to placebo in the context of a multimodal analgesic regimen. A larger study is required.

Does the use of glycerin laxatives decrease feeding intolerance in preterm infants?

BACKGROUND: Glycerin laxatives are often prescribed in the neonatal population for meconium evacuation and to promote enteral feeding. However, the literature regarding their effectiveness has not been systematically reviewed. OBJECTIVE: To assess the effectiveness of glycerin enema or suppository in preventing feeding intolerance in preterm infants at ≤32 weeks' gestational age or weighing ≤1500 g at birth. METHODS: The Medline, Embase, Cochrane Library, Scopus and Web of Science databases were searched to identify studies that evaluated glycerin enemas/suppositories for feeding intolerance. Using the Evidence Evaluation Worksheet adapted from the American Heart Association's International Liaison Committee on Resuscitation, eligible studies were scored for quality, level of evidence and direction of support. RESULTS: Two clinical studies that evaluated meconium evacuation and feeding intolerance were included. One study showed no difference in the time to complete meconium evacuation or establishment of full enteral feeds, while the other showed that the times to first meconium passage and full enteral feeding were significantly shorter, and the rate of sepsis was lower in the glycerin enema group. CONCLUSION: The evidence regarding the effectiveness of glycerin laxatives for improving feeding tolerance is inconclusive in infants at ≤32 weeks' gestational age or weighing ≤1500 g at birth.