Simulation-based team training improved the self-assessed ability of physicians, nurses and midwives to perform neonatal resuscitation.

AIM: The use of simulation-based team training in neonatal resuscitation has increased in Sweden during the last decade, but no formal evaluation of this training method has been performed. This study evaluated the effect of simulation-based team training on the self-assessed ability of personnel to perform neonatal resuscitation. METHODS: We evaluated a full-day simulation-based team training course in neonatal resuscitation, by administering a questionnaire to 110 physicians, nurses and midwives before and after the training period. The questionnaire focused on four important domains: communication, leadership, confidence and technical skills. The study was carried out in Sweden from 2005 to 2007. RESULTS: The response rate was 84%. Improvements in the participants' self-assessed ability to perform neonatal resuscitation were seen in all four domains after training (p < 0.001). Professionally inexperienced personnel showed a significant improvement in the technical skills domain compared to experienced personnel (p = 0.001). No differences were seen between professions or time since training in any of the four domains. Personnel with less previous experience with neonatal resuscitation showed improved confidence (p = 0.007) and technical skills (p = 0.003). CONCLUSION: A full-day course on simulation-based team training with video-supported debriefing improved the participants' self-assessed ability to perform neonatal resuscitation.

Improved postnatal care is needed to maintain gains in neonatal survival after the implementation of the Helping Babies Breathe initiative.

AIM: Helping Babies Breathe (HBB) is a neonatal resuscitation protocol proven to reduce intrapartum-related mortality in low-income settings. The aim of this study was to describe the timing and causes of neonatal in-hospital deaths before and after HBB training at a maternity health facility in Nepal. METHODS: A prospective cohort study was conducted at the facility between July 2012 and September 2013. All 137 staffs, including medical doctors and midwives, were trained in January 2013. The causes of 299 neonatal deaths and the day of death, up to 27 days, were collected before and after the training course. RESULTS: Deaths caused by intrapartum-related complications were reduced from 51% to 33%. Preterm infants survived for more days (p < 0.01) during the neonatal period, but overall in-hospital neonatal mortality was unchanged (p = 0.46) after training. The survival rates linked to complications of infection, congenital anomalies and other causes were unaffected by the intervention. CONCLUSION: The continuum of postnatal care for newborn infants needs to be strengthened after Helping Babies Breathe training, to maintain the gains in neonatal survival on the day of delivery. Additional interventions in the postnatal period are therefore required to increase neonatal survival at facilities in low-income settings.

Ophthalmological outcome and visuospatial ability in very preterm children measured at 2.5 years corrected age.

AIM: To investigate the ophthalmological outcome of very preterm children at 2.5 years corrected age (CA) and perform a test of visuospatial and cognitive abilities. METHODS: A population-based, prospective study (LOVIS study) in Uppsala County, Sweden, comprised 111 very preterm children (<32 w gestational age [GA]) born between 1 January 2004 and 31 December 2007. Ophthalmic evaluations were undertaken in 98/109 children (89.9%) alive at 2.5 years. Spatial cognition was investigated with a test of five alternative blocks in 48 preterm and 25 term-born children. RESULTS: Visual impairment, strabismus or refractive errors, were found in 12% of the children. None of the children were blind in both eyes. Logistic regression analyses revealed significant associations between strabismus and periventricular leucomalacia/intraventricular haemorrhage (OR 9.6, p = 0.025) and between refractive errors and severe retinopathy of prematurity (OR 9.8, p = 0.011) and GA (OR 0.763, p = 0.034). Oval and rectangular blocks were significantly more difficult to insert into a box for preterm than full-term children (p = 0.048 and 0.013, respectively). There was a significant correlation between total scores for the five blocks and GA at birth (p = 0.035). CONCLUSION: Eye and visual problems were found in 12% of the preterm children at 30 months CA. Preterm children had difficulties with blocks of complex shapes.

Cytomegalovirus-specific CD4 and CD8 T cell responses in infants and children.

Congenital cytomegalovirus (CMV) infection is the most common congenital infection causing childhood morbidity. The pathogenetic mechanisms behind long-term sequelae are unclear, but long-standing viremia as a consequence of the inability to convert the virus to a latent state has been suggested to be involved. Whereas primary CMV infection in adults is typically rapidly controlled by the immune system, children have been shown to excrete virus for years. Here, we compare T cell responses in children with congenital CMV infection, children with postnatal CMV infection and adults with symptomatic primary CMV infection. The study groups included 24 children with congenital CMV infection, 19 children with postnatal CMV infection and eight adults with primary CMV infection. Among the infants with congenital CMV infection, 13 were symptomatic. T cell responses were determined by analysis of interferon gamma production after stimulation with CMV antigen. Our results show that whereas adults display high CMV-specific CD4 T cell responses in the initial phase of the infection, children younger than 2 years have low or undetectable responses that appear to increase with time. There were no differences between groups with regard to CD8 T cell function. In conclusion, inadequate CD 4 T cell function seems to be involved in the failure to get immune control of the CMV infection in children younger than 2 years of age with congenital as well as postnatal CMV infection.

State of the art and recommendations. Kangaroo mother care: application in a high-tech environment.

UNLABELLED: Since Kangaroo Mother Care (KMC) was developed in Colombia in the 1970s, two trends in clinical application emerged. In low income settings, the original KMC model is implemented. This consists of continuous (24 h/day, 7 days/week) and prolonged mother/parent-infant skin-to-skin contact; early discharge with the infant in the kangaroo position; (ideally) exclusive breastfeeding; and, adequate follow-up. In affluent settings, intermittent KMC with sessions of one or a few hours skin-to-skin contact for a limited period is common. As a result of the increasing evidence of the benefits of KMC for both infants and families in all intensive care settings, KMC in a high-tech environment was chosen as the topic for the first European Conference on KMC, and the clinical implementation of the KMC model in all types of settings was discussed at the 7th International Workshop on KMC. Kangaroo Mother Care protocols in high-tech Neonatal Intensive Care Units (NICU) should specify criteria for initiation, kangaroo position, transfer to/from KMC, transport in kangaroo position, kangaroo nutrition, parents' role, modification of the NICU environment, performance of care in KMC, and KMC in case of infant instability. CONCLUSION: Implementation of the original KMC method, with continuous skin-to-skin contact whenever possible, is recommended for application in high-tech environments, although scientific evaluation should continue.

Towards universal Kangaroo Mother Care: recommendations and report from the First European conference and Seventh International Workshop on Kangaroo Mother Care.

UNLABELLED: The hallmark of Kangaroo Mother Care (KMC) is the kangaroo position: the infant is cared for skin-to-skin vertically between the mother's breasts and below her clothes, 24 h/day, with father/substitute(s) participating as KMC providers. Intermittent KMC (for short periods once or a few times per day, for a variable number of days) is commonly employed in high-tech neonatal intensive care units. These two modalities should be regarded as a progressive adaptation of the mother-infant dyad, ideally towards continuous KMC, starting gradually and progressively with intermittent KMC. The other components in KMC are exclusive breastfeeding (ideally) and early discharge in kangaroo position with strict follow-up. Current evidence allows the following general statements about KMC in affluent and low-income settings: KMC enhances bonding and attachment; reduces maternal postpartum depression symptoms; enhances infant physiologic stability and reduces pain, increases parental sensitivity to infant cues; contributes to the establishment and longer duration of breastfeeding and has positive effects on infant development and infant/parent interaction. Therefore, intrapartum and postnatal care in all types of settings should adhere to a paradigm of nonseparation of infants and their mothers/families. Preterm/low-birth-weight infants should be regarded as extero-gestational foetuses needing skin-to-skin contact to promote maturation. CONCLUSION: Kangaroo Mother Care should begin as soon as possible after birth, be applied as continuous skin-to-skin contact to the extent that this is possible and appropriate and continue for as long as appropriate.

State of the art and recommendations. Kangaroo mother care: application in a high-tech environment.

UNLABELLED: Since Kangaroo Mother Care (KMC) was developed in Colombia in the 1970s, two trends in clinical application emerged. In low-income settings, the original KMC modelis implemented. This consists of continuous (24 h/day; 7 days/week) and prolonged mother/parent-infant skin-to-skin contact; early discharge with the infant in the kangaroo position; (ideally) exclusive breastfeeding and, adequate follow up. In affluent settings, intermittent KMC with sessions of one or a few hours skin-to-skin contact for a limited period is common. As a result of the increasing evidence of the benefits of KMC for both infants and families in all intensive care settings, KMC in a high-tech environment was chosen as the topic for the first European Conference on KMC, and the clinical implementation of the KMC modelin all types of settings was discussed at the 7th International Workshop on KMC Kangaroo Mother Care protocols in high-tech Neonatal Intensive Care Units (NICU) should specify criteria for initiation, kangaroo position, transfer to/from KMC, transport in kangaroo position, kangaroo nutrition, parents'role, modification of the NICU environment, performance of care in KMC, and KMCin case of infant instability. CONCLUSION: Implementation of the original KMC method, with continuous skin-to-skin contact whenever possible, is recommended for application in high-tech environments, although scientific evaluation should continue.

Delivery care utilisation and care-seeking in the neonatal period: a population-based study in Vietnam.

BACKGROUND: If millions of neonatal deaths each year are to be prevented, one crucial component that must be improved is adequate care-seeking behaviour and effective use of existing health care systems. We have investigated these factors in relation to delivery and the neonatal period in a province in Northern Vietnam, a setting currently in socio-economic transition. METHODS: Information on births and neonatal deaths between January and December 2005 in Quang Ninh province was collected. Narratives of the neonatal deaths were gathered and information about care-seeking in relation to delivery and illness was extracted. This information was then compared with the time and place of delivery and death. RESULTS: We registered 17,519 births and 284 neonatal deaths occurring between January and December 2005. The neonatal mortality rate varied from 7.5/1000 to 38/1000, depending on the place of delivery. A quarter of the neonatal deaths had no contact with the health-care system at the time of death. Neonatal death within 24 hours of birth was more likely when the mother did not seek care at the time of delivery, or did so at the lowest level of the system (chi2=35.5, p<0.001). Mothers of ethnic minorities were more likely to exhibit this care-seeking behaviour at delivery. CONCLUSION: Further improvement in neonatal survival can be achieved by changes in health system utilisation that aim to secure safe delivery for pregnant women. More efforts at local level are needed to encourage adequate care-seeking.

Human serum amyloid A (SAA) and high sensitive C-reactive protein (hsCRP) in preterm newborn infants with nosocomial infections.

UNLABELLED: Human serum amyloid A (SAA) and high sensitive C-reactive protein (hsCRP) and their relation to suggestive nosocomial infections (NIs) were investigated in very preterm (VPT) newborn infants. In a retrospective analysis, information of suggestive NI was matched to levels of SAA and hsCRP in 224 serum samples from 72 VPT newborn infants. As a control group, 35 healthy-term newborn infants were chosen. Of the 224 serum samples, 145 samples were not associated with nosocomial infections. However, 79 were associated with NI: of these 79, 42 were found to be culture-proven NI. Trimmed mean (alpha= 0.05) levels for SAA and hsCRP in VPT newborn infants were higher than in control term newborn infants (1.74, 2.67 mg/L vs. 0.78, 0.16 mg/L; p = 0.01 and <0.0001, respectively), and higher in the NI group than in the non-NI group (5.14, 5.74 mg/L vs. 1.03, 1.18; p < 0.01 and <0.0001; respectively). The areas under the curve (AUC) for hsCRP, calculated from the receiver-operator characteristic (ROC) curves, was greater (0.816; 95% CI 0.759-0.864) than for SAA (0.610; 95% CI 0.543-0.675). CONCLUSION: Identifying and monitoring of bacterial and fungal infections in VPT might be further improved by the use of SAA and hsCRP.

Perinatal and socioeconomic determinants of breastfeeding duration in very preterm infants.

AIM: To describe the impact of prematurity, size at birth, neonatal disorders and the families' socioeconomic status (SES) on breastfeeding duration in mothers of very preterm infants. METHODS: Prospective population-based cohort study. Data on breastfeeding, registered in databases in two Swedish counties in 1993-2001, were matched with data from two national registries: the Medical Birth Registry and Statistics Sweden. Mothers of 225 very preterm singleton infants were identified and included. RESULTS: Seventy-nine percent of the mothers breastfed at 2 months, 62% at 4 months, 45% at 6 months, 22% at 9 months and 12% at 12 months. Prematurity, size at birth and neonatal disorders did not show an effect on breastfeeding duration. Being adversely exposed to any of the SES factors (maternal education, unemployment benefit, social welfare and equivalent disposable income in the household) was significantly associated with earlier weaning up to 6 months of infants' postnatal age. CONCLUSIONS: This study shows new and noteworthy results concerning breastfeeding duration in mothers of very preterm infants, which was not influenced by degree of prematurity, size at birth or neonatal disorders but was affected by SES. This highlights the need for improved support of socioeconomically disadvantaged mothers, during and after the hospital stay.

CD64 (Fcgamma receptor I) cell surface expression on maturing neutrophils from preterm and term newborn infants.

BACKGROUND: The expression of CD64 (FcgammaRI) is increased from an almost negligible to a marked level on neutrophils in patients with bacterial infections. CD64 expression on neutrophils might therefore be a potential candidate for the diagnosis of bacterial infections in infants. AIM: This study was performed to monitor changes of neutrophil expression of CD64 during the postpartum period to further evaluate the usefulness of this analysis. The possible influence on the expression of this receptor by other factors was also investigated, including respiratory distress syndrome (RDS) and preterm rupture of the membranes (PROM). METHODS: Cell surface expression of CD64 on neutrophils from preterm and term newborn infants and healthy adults was analysed by flow cytometry. The expression of the other Fcgamma receptors, CD32 and CD16, and the complement receptors CD11b/CD18 and CD35 was also analysed for comparison. RESULTS: Neutrophils from preterm newborn infants showed a moderately increased level of CD64 expression that, during their first month of life, was reduced to the level observed on neutrophils from term newborn infants and adults. In contrast, the level of neutrophil expression of CD32 and CD16 was significantly lower in preterm than term newborn infants and adults. Neutrophils from all groups indicated similar levels of CD11b expression, but the expression on neutrophils from newborn infants increased after birth. CONCLUSION: Our results showed that neutrophil expression of CD64 is moderately increased in preterm newborn infants at birth. It seems not to be influenced by RDS, PROM or other factors related to preterm birth but by bacterial infection.

Appropriate prophylaxis with restrictive palivizumab regimen in preterm children in Sweden.

AIM: Palivizumab (Synagis) was registered in Sweden in 1999 for prophylaxis against respiratory syncytial virus (RSV) in premature infants. The high costs and the limited knowledge of the efficacy of this substance have led to debate about how and when it should be used. National guidelines for the use of palivizumab in Sweden were constructed in the year 2000. The aim of this study was to evaluate the guidelines. METHODS: A nation-wide prospective study was conducted during the two RSV seasons of the years 2000-2002. The paediatric departments in Sweden reported the use of palivizumab, the indication for its use, and the number of infants born preterm before 36 wk of gestation and less than 2 y old who were admitted to hospital for RSV infection. RESULTS: During the two seasons, 218 (3.8%) children who were born before 36 wk of gestation, and 97 (5.4%) who were born before 33 wk, were hospitalized because of RSV infection. Five children were treated with mechanical ventilation. No death caused by RSV was reported. A total of 390 children were treated with palivizumab, and 16 (4.1%) of those who received prophylactic treatment were admitted to hospital with RSV infection. CONCLUSION: We consider the comparatively restrictive Swedish recommendations to be safe and recommend that palivizumab should also be used very restrictively in the future. In our opinion, palivizumab in preterm children could be recommended only for those with chronic lung disease younger than 1 y of age, and with active treatment for their disease.

Short-term outcome after active perinatal management at 23-25 weeks of gestation. A study from two Swedish tertiary care centres. Part 2: infant survival.

AIM: To determine neonatal survival rates based on both foetal (stillborn) and neonatal deaths among infants delivered at 23-25 wk, and to identify maternal and neonatal factors associated with survival. METHODS: The medical records of 224 infants who were delivered in two tertiary care centres in 1992-1998 were reviewed retrospectively. At these centres, policies of active perinatal and neonatal management were universally applied. Data were analysed by gestational age groups and considered in three time periods. Logistic regression models were used to identify factors associated with survival. RESULTS: The rate of foetal death was 5%. Of infants born alive, 63% survived to discharge. Survival rates including foetal deaths in the denominator at 23, 24 and 25 wk were 37%, 61% and 74%, respectively, and survival rates excluding foetal deaths were 43%, 63% and 77%, respectively. Of infants born with 1-min Apgar scores of 0-1, 43% survived. In the total cohort, survival rates including foetal deaths in the denominator increased from 52% in time period 1 to 61% in time period 2 and 74% in time period 3 (p < 0.02). On multivariate logistic regression analysis, higher birthweight (OR: 1.91 per 100 g increment; 95% CI: 1.45-2.52), female gender (OR: 3.33; 95% CI: 1.65-6.75), administration of antenatal steroids (OR: 2.95; 95% CI: 1.46-5.98) and intrauterine referral from a peripheral hospital (OR: 2.35; 95% CI: 1.18-4.68) were associated with survival. Apgar score < or = 3 at 1 min (OR: 0.46; 95% CI: 0.22-0.95) was associated with decreased survival. The use of antenatal steroids was protective at 23-24 wk (OR: 5.2; 95% CI: 2.0-13.7), but not at 25 wk. CONCLUSIONS: Active perinatal management that included universal initiation of neonatal intensive care virtually eliminated intrapartum stillbirths and delivery room deaths, and resulted in survival rates that compare favourably with those of recent studies. However, the policies of active care postponed death in non-survivors. Individual variations in outcome in relation to the infant's condition at birth as reflected by the Apgar scores preclude the making of treatment decisions in the delivery room.

Short-term outcome after active perinatal management at 23-25 weeks of gestation. A study from two Swedish perinatal centres. Part 3: neonatal morbidity.

AIM: To determine major neonatal morbidity in surviving infants born at 23-25 weeks, and to identify maternal and infant factors associated with major morbidity. METHODS: The medical records of 224 infants who were delivered at two tertiary care centres in 1992-1998 were reviewed retrospectively. At these centres, policies of active perinatal and neonatal management were universally applied. Of the 213 liveborn infants, 140 (66%) survived to discharge. Data were analysed by gestational age and considered in three time periods. Logistic regression models were used to identify factors associated with morbidity. RESULTS: Of the survivors, 6% had intraventricular haemorrhage grade > or = 3 (severe IVH) or periventricular leukomalacia (PVL), 15% retinopathy of prematurity > or = stage 3 (severe ROP) and 36% bronchopulmonary dysplasia (BPD). On logistic regression analysis, severe IVH or PVL was associated with duration of mechanical ventilation (odds ratio, OR: 1.53 per 1-wk increment in duration; 95% confidence interval, CI: 1.01-2.33). Severe ROP was associated with the presence of a patent ductus arteriosus (PDA) (OR: 3.31; 95% CI: 1.11-9.90) and birth in time period 3 versus time periods 1 and 2 combined (OR: 6.28; 95% CI: 2.10-18.74). BPD was associated with duration of mechanical ventilation (OR: 2.71 per 1-wk increment in duration; 95% CI: 1.76-4.18) and with the presence of any obstetric complication (OR: 2.67; 95% CI: 1.07-6.65). Gestational age and birthweight were not associated with major morbidity. Of all survivors, 81% were discharged home without severe IVH, PVL or severe ROP. CONCLUSIONS: Increased survival as a result of active perinatal and neonatal management was associated with favourable morbidity rates compared with those in recent studies. Among survivors born at 23-25 weeks, neither gestational age nor birthweight was a significant determinant of major morbidity.

Short-term outcome after active perinatal management at 23-25 weeks of gestation. A study from two Swedish tertiary care centres. Part 1: maternal and obstetric factors.

AIMS: To provide descriptive data on women who delivered at 23-25 wk of gestation, and to relate foetal and neonatal outcomes to maternal factors, obstetric management and the principal reasons for preterm birth. METHODS: Medical records of all women who had delivered in two tertiary care centres in 1992-1998 were reviewed. At the two centres, policies of active perinatal and neonatal management were universally applied. Logistic regression models were used to identify prenatal factors associated with survival. RESULTS: Of 197 women who delivered at 23-25 wk, 65% had experienced a previous miscarriage, 15% a previous stillbirth and 12% a neonatal death. The current pregnancy was the result of artificial reproduction in 13% of the women. In 71%, the pregnancy was complicated either by pre-eclampsia, chorioamnionitis, placental abruption or premature rupture of membranes. Antenatal steroids were given in 63%. Delivery was by caesarean section in 47%. The reasons for preterm birth were idiopathic preterm labour in 36%, premature rupture of membranes in 41% and physician-indicated deliveries in 23% of the mothers. Demographic details, use of antenatal steroids, caesarean section delivery and birthweight differed between mothers depending on the reason for preterm delivery. Of 224 infants, 5% were stillbirths and 63% survived to discharge. On multivariate logistic regression analysis comprising prenatally known variables, reasons for preterm birth were not associated with survival. Advanced gestational duration (OR: 2.43 per wk; 95% CI: 1.59-3.74), administration of any antenatal steroids (OR: 2.21; 95% Cl: 1.14-4.28) and intrauterine referral from a peripheral hospital (OR: 2.93; 95% CI: 1.5-5.73) were associated with survival. CONCLUSIONS: Women who deliver at 23-25 wk comprise a risk group characterized by a high risk of reproductive failure and pregnancy complications. Survival rates were similar regardless of the reason for preterm birth. Policies of active perinatal management virtually eliminated intrapartum stillbirths.

The rate of candidaemia in preterm infants born at a gestational age of 23-28 weeks is inversely correlated to gestational age.

AIM: To assess the rate of candidaemia and the associated case fatality rate in relation to gestational age, and the variation in the rate of candidaemia over time in the neonatal period. METHODS: Retrospective review of medical records of infants with a positive blood culture for fungi while in the neonatal unit, Uppsala University Children's Hospital or at autopsy following death in the unit from 1994 to 2001 (n = 30). RESULTS: The number of cases per year was found to vary between zero and eight. The annual rate of infection did not change significantly during the study period. The preterm infants with candidaemia (n = 29) were born at a gestational age ranging from 23-28 wk. The rate of candidaemia in this group was inversely related to gestational age and varied from 2 to 24%. Five infants (17%) died from Candida infection. Of these five, four were born at a gestational age of 23 wk. CONCLUSION: candidaemia in newborns occurs predominately in infants born at a gestational age < or =28 wk, where the rate of infection is inversely correlated to gestational age in infants born at a gestational age of 23-28 wk. The highest case fatality rate is observed in infants born at a gestational age of 23 wk.

Progress of unit based quality improvement: an evaluation of a support strategy.

OBJECTIVE: To evaluate a strategy for supporting nurses to work with quality improvement (QI). DESIGN: Post-intervention evaluation. Study participants and intervention: 240 nurses participated in a uniformly designed 4 day basic training course in applying a model for QI. Of these, 156 nurses from over 50 healthcare institutions constituted the generic education (GE) group while 84 nurses from 42 neonatal units took part in a project to develop national guidelines, constituting the targeted intervention (TI) group. METHOD: Postal questionnaire 4 years after the training courses. RESULTS: The response rate was 80% in the TI group and 64% in the GE group. Nurses in the TI group had a significantly higher rate in completing all phases of the QI cycle (p=0.0002). With no differences between the groups, 39% of all nurses were still involved in QI work 4 years after the training courses. Three factors were significantly related to nurses continuing their involvement in QI projects: remaining employed on the same unit (OR 11.3), taking courses in nursing science (OR 4.1), and maintenance of the same QI model (OR 3.1). Reported motives for remaining active in QI work were the enhancement of knowledge, influence over clinical practice, and development as a nurse. Reasons for discontinuation were organisational restructuring, a lack of facilitation and knowledge, and change of workplace. CONCLUSIONS: Participation in a national guideline project, including a common focus for improvement, facilitation and opportunities for networking, seems to have enhanced the ability to carry out the process of QI, but not to sustain the QI work over a longer period.

Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses.

BACKGROUND: Balsalazide is a new 5-aminosalicylic acid (5-ASA) containing prodrug. Its efficacy in comparison with standard mesalazine therapy and the optimum dose for maintaining remission of ulcerative colitis are still unclear. AIMS: To compare the relapse preventing effect and safety profile of two doses of balsalazide and a standard dose of Eudragit coated mesalazine. METHODS: A total of 133 patients with ulcerative colitis in remission were recruited to participate in a double blind, multicentre, randomised trial: 49 patients received balsalazide 1.5 g twice daily, 40 received balsalazide 3.0 g twice daily, and 44 received mesalazine 0.5 g three times daily. Efficacy assessments were clinical activity index (CAI) and endoscopic score according to Rachmilewitz, and a histological score. In addition, laboratory tests were performed and urinary excretion of 5-ASA and its metabolite N-Ac-5-ASA was analysed. The study lasted for 26 weeks. RESULTS: Balsalazide 3.0 g twice daily resulted in a significantly higher clinical remission rate (77.5%) than balsalazide 1.5 g twice daily (43.8%) and mesalazine 0.5 g three times daily (56.8%) (p=0.006). The respective times to relapse were 161 days, 131 days (p=0.003), and 144 days (NS). Accordingly, pairwise contrasts of the final endoscopic score demonstrated a significant difference (p=0.005) between the two balsalazide treatment groups while differences between either of these two groups and mesalazine were not statistically significant. Patients treated with balsalazide excreted less 5-ASA and N-Ac-5-ASA than patients receiving mesalazine but these differences were not statistically significant. Discontinuation of the trial because of adverse effects occurred in nine patients: three in the balsalazide 1.5 g twice daily group, two in the balsalazide 3.0 g twice daily group, and four in the mesalazine 0.5 g three times daily group. No clinically important new drug safety related findings were identified in this study. CONCLUSIONS: High dose balsalazide (3.0 g twice daily) was superior in maintaining remission in patients with ulcerative colitis compared with a low dose (1.5 g twice daily) or a standard dose of mesalazine (0.5 g three times daily). All three treatments were safe and well tolerated.

Early oral behaviour in preterm infants during breastfeeding: an electromyographic study.

UNLABELLED: The objectives were to increase the understanding of the characteristics of oral behaviour during breastfeeding in preterm infants and to validate direct observations of infant sucking. Twenty-six infants were investigated once by simultaneous observation and surface electromyography (EMG) at 32.1-37.1 postmenstrual weeks. The orbicularis oris muscle was used for data analysis, as it provided the most distinct registrations. High correlation coefficients were observed with respect to classifications of EMG data by two raters on the number of sucks per burst (r = 0.97) and duration of sucking bursts (r = 0.99). The agreement between direct observations of sucking and EMG data was high. The median for mean number of sucks per burst was 8 (range 2-33) and for longest burst 28 (5-96) sucks. Sucks with low and very high intensity constituted a median of 14 (1-94)% and 25 (0-87)% of all sucks. The range in mean sucking frequency was 1.0-1.8 sucks s(-1). Suck duration ranged from 0.6 to 1.1 s. There was a considerable variation between infants in the extent of mouthing. No association with maturational level appeared for any of the components in oral behaviour. CONCLUSION: EMG data provided evidence of early sucking competence in preterm infants during breastfeeding, with wide individual variations. Surface EMG and direct observation are recommended as valid methods in the evaluation of breastfeeding behaviour in preterm infants.

Errors in estimating neonatal production of glucose with stable isotopes during "approximate steady state".

In studies of glucose metabolism in neonates, a commonly used approach is based on constant rate infusion of glucose labelled with a stable isotope in order to reach an approximate steady state with regard to isotopic enrichment in plasma. Under presumed conditions of a glucose steady state, the rates of appearance and disappearance of glucose can, in principle, be calculated with use of a simple steady-state formula. However, in the neonate, steady-state conditions do not generally prevail and results derived on such assumptions are questionable. In the present study, we have taken a pragmatic approach and compared estimates obtained from the conventional formula with values calculated with Steele's non-steady-state method. The results show that the estimated glucose appearance and disappearance rates change more or less over the observed time period in all the typical cases studied, and that "steady-state estimates" may differ from the corresponding non-steady-state values by up to 37%. In a sensitivity analysis, the value of the distribution volume factor was found to be non-critical, a circumstance that supports the use of Steele's method. Thus, even though the classical Steele pool-fraction method for computation of rates of appearance and disappearance under non-steady-state conditions has been criticized, it is still the most realistic alternative to the frequently used simple steady-state formula in applications to newborns.