Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in Uganda: study protocol.

BACKGROUND: There is now convincing evidence that in industrialized countries therapeutic hypothermia for perinatal asphyxial encephalopathy increases survival with normal neurological function. However, the greatest burden of perinatal asphyxia falls in low and mid-resource settings where it is unclear whether therapeutic hypothermia is safe and effective. AIMS: Under the UCL Uganda Women's Health Initiative, a pilot randomized controlled trial in infants with perinatal asphyxia was set up in the special care baby unit in Mulago Hospital, a large public hospital with ~20,000 births in Kampala, Uganda to determine:(i) The feasibility of achieving consent, neurological assessment, randomization and whole body cooling to a core temperature 33-34°C using water bottles(ii) The temperature profile of encephalopathic infants with standard care(iii) The pattern, severity and evolution of brain tissue injury as seen on cranial ultrasound and relation with outcome(iv) The feasibility of neurodevelopmental follow-up at 18-22 months of age METHODS/DESIGN: Ethical approval was obtained from Makerere University and Mulago Hospital. All infants were in-born. Parental consent for entry into the trial was obtained. Thirty-six infants were randomized either to standard care plus cooling (target rectal temperature of 33-34°C for 72 hrs, started within 3 h of birth) or standard care alone. All other aspects of management were the same. Cooling was performed using water bottles filled with tepid tap water (25°C). Rectal, axillary, ambient and surface water bottle temperatures were monitored continuously for the first 80 h. Encephalopathy scoring was performed on days 1-4, a structured, scorable neurological examination and head circumference were performed on days 7 and 17. Cranial ultrasound was performed on days 1, 3 and 7 and scored. Griffiths developmental quotient, head circumference, neurological examination and assessment of gross motor function were obtained at 18-22 months. DISCUSSION: We will highlight differences in neonatal care and infrastructure that need to be taken into account when considering a large safety and efficacy RCT of therapeutic hypothermia in low and mid resource settings in the future. TRIAL REGISTRATION: Current controlled trials ISRCTN92213707.

Improvement in neonatal intensive care unit care: a cluster randomised controlled trial of active dissemination of information.

BACKGROUND: Research findings are not rapidly or fully implemented into policies and practice in care. OBJECTIVES: To assess whether an 'active' strategy was more likely to lead to changes in policy and practice in preterm baby care than traditional information dissemination. DESIGN: Cluster randomised trial. PARTICIPANTS: 180 neonatal units (87 active, 93 control) in England; clinicians from active arm units; babies born <27 weeks gestation. CONTROL ARM: Dissemination of research report; slides; information about newborn care position statement. ACTIVE ARM: As above plus offer to become 'regional 'champion' (attend two workshops, support clinicians to implement research evidence regionally), or attend one workshop, promote implementation of research evidence locally. MAIN OUTCOME MEASURES: timing of surfactant administration; admission temperature; staffing of resuscitation team present at birth. RESULTS: 48/87 Lead clinicians in the active arm attended one or both workshops. There was no evidence of difference in post-intervention policies between trial arms. Practice outcomes based on babies in the active (169) and control arms (186), in 45 and 49 neonatal units respectively, showed active arm babies were more likely to have been given surfactant on labour ward (RR=1.30; 95% CI 0.99 to 1.70); p=0.06); to have a higher temperature on admission to neonatal intensive care unit (mean difference=0.29(o)C; 95% CI 0.22 to 0.55; p=0.03); and to have had the baby's trunk delivered into a plastic bag (RR=1.27; 95% CI 1.01 to 1.60; p=0.04) than the control group. The effect on having an 'ideal' resuscitation team at birth was in the same direction of benefit for the active arm (RR=1.18; 95% CI 0.97 to 1.43; p=0.09). The costs of the intervention were modest. CONCLUSIONS: This is the first trial to evaluate methods for transferring information from neonatal research into local policies and practice in England. An active approach to research dissemination is both feasible and cost-effective. TRIAL REGISTRATION: Current controlled trials ISRCTN89683698.

The BLISS cluster randomised controlled trial of the effect of 'active dissemination of information' on standards of care for premature babies in England (BEADI) study protocol [ISRCTN89683698].

BACKGROUND: Gaps between research knowledge and practice have been consistently reported. Traditional ways of communicating information have limited impact on practice changes. Strategies to disseminate information need to be more interactive and based on techniques reported in systematic reviews of implementation of changes. There is a need for clarification as to which dissemination strategies work best to translate evidence into practice in neonatal units across England. The objective of this trial is to assess whether an innovative active strategy for the dissemination of neonatal research findings, recommendations, and national neonatal guidelines is more likely to lead to changes in policy and practice than the traditional (more passive) forms of dissemination in England. METHODS/DESIGN: Cluster randomised controlled trial of all neonatal units in England (randomised by hospital, n = 182 and stratified by neonatal regional networks and neonatal units level of care) to assess the relative effectiveness of active dissemination strategies on changes in local policies and practices. Participants will be mainly consultant lead clinicians in each unit. The intervention will be multifaceted using: audit and feedback; educational meetings for local staff (evidence-based lectures on selected topics, interactive workshop to examine current practice and draw up plans for change); and quality improvement and organisational changes methods. Policies and practice outcomes for the babies involved will be collected before and after the intervention. Outcomes will assess all premature babies born in England during a three month period for timing of surfactant administration at birth, temperature control at birth, and resuscitation team (qualification and numbers) present at birth.

Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland: population based study.

OBJECTIVE: To provide perinatal mortality and congenital anomaly rates for babies born to women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland. DESIGN: National population based pregnancy cohort. SETTING: 231 maternity units in England, Wales, and Northern Ireland. PARTICIPANTS: 2359 pregnancies to women with type 1 or type 2 diabetes who delivered between 1 March 2002 and 28 February 2003. MAIN OUTCOME MEASURES: Stillbirth rates; perinatal and neonatal mortality; prevalence of congenital anomalies. RESULTS: Of 2359 women with diabetes, 652 had type 2 diabetes and 1707 had type 1 diabetes. Women with type 2 diabetes were more likely to come from a Black, Asian, or other ethnic minority group (type 2, 48.8%; type 1, 9.1%) and from a deprived area (type 2, 46.3% in most deprived fifth; type 1, 22.8%). Perinatal mortality in babies of women with diabetes was 31.8/1000 births. Perinatal mortality was comparable in babies of women with type 1 (31.7/1000 births) and type 2 diabetes (32.3/1000) and was nearly four times higher than that in the general maternity population. 141 major congenital anomalies were confirmed in 109 offspring. The prevalence of major congenital anomaly was 46/1000 births in women with diabetes (48/1000 births for type 1 diabetes; 43/1000 for type 2 diabetes), more than double that expected. This increase was driven by anomalies of the nervous system, notably neural tube defects (4.2-fold), and congenital heart disease (3.4-fold). Anomalies in 71/109 (65%) offspring were diagnosed antenatally. Congenital heart disease was diagnosed antenatally in 23/42 (54.8%) offspring; anomalies other than congenital heart disease were diagnosed antenatally in 48/67 (71.6%) offspring. CONCLUSION: Perinatal mortality and prevalence of congenital anomalies are high in the babies of women with type 1 or type 2 diabetes. The rates do not seem to differ between the two types of diabetes.

Project 27/28: inquiry into quality of neonatal care and its effect on the survival of infants who were born at 27 and 28 weeks in England, Wales, and Northern Ireland.

OBJECTIVE: To identify variations in standards of neonatal care in the first week of life that might have contributed to deaths in infants who were born at 27 and 28 weeks' gestation. METHODS: A case-control study was conducted of infants who were born at 27 and 28 weeks' gestation in England, Wales, and Northern Ireland during a 2-year period. Cases were neonatal deaths; control subjects were randomly selected survivors at day 28. Main outcome measures were failures of prespecified standards of care or deficiencies in care reported by regional panels assessing anonymized medical records. RESULTS: Failures of standards of care relating to ventilatory support (adjusted odds ratio [OR]: 3.29; 95% confidence interval [CI]: 1.97-5.49), cardiovascular support (OR: 2.37; 95% CI :1.36-4.13), and thermal care (OR: 1.71; 95% CI: 1.21-2.43) were associated with neonatal death. Frequencies of unmet resuscitation standards (range: 3%-46%) and of delays in surfactant administration (range: 38%-40%) were similar in cases and control subjects. Panels identified significantly more deficiencies in all aspects of neonatal care in cases with the exception of the management of infection. Stratification by clinical condition of infants at birth showed a stronger association between overall standard of care and death when infants were in a good condition at birth. CONCLUSIONS: Our findings suggest an association between quality of neonatal care and neonatal deaths, most marked for early thermal care and ventilatory and cardiovascular support. Poor overall quality of care was more strongly associated with deaths when the infant was in a good condition at birth.

Fetal gallstones.

The significance and natural history of fetal cholelithiasis is not yet well defined. We report two cases of echogenic foci detected prenatally by ultrasound. The gallstones resolved in both cases by 16 weeks following birth. Both infants were treated by ursodeoxycholic acid.

Morbidade neurológica di récen-nascido a termo e incidência de cesarianas na cidade do Rio de Janeiro: estudo colaborativo de quatro maternidades publicas / Neurological morbidity of a full term newborn and the incidence of cesarian section in Rio de Janeiro City: a colaborative study of four public hospitals

De setembro de 1989 a maio de 1990, 2.188 recém-nascidos a termo (entre 37 semanas e 41 semanas e seis dias), provenientes de 2.414 partos consecutivos de quatro Maternidades Públicas da Cidade do Rio de Janeiro tiveram um exame clínico neurológico realizado durante a primeira semana de vida. Segundo esse exame, as crianças neurologicamente anormais puderam ser classificadas em três graus de sofrimento cerebral: leve, moderado e grave, cada um ligado a um risco estatístico de seqüelas neurológicas na infância. Só foram retidos para nossa casuística os casos obviamente relacionados a uma origem gestacional e/ou obstétrica. Neste estudo 50,5 crianças por 1.000 nascimentos a termo evidenciaram sinais clínicos neurológicos devidos à asfixia contra quatro a seis por 1.000 nos países europeus. As formas moderada e grave de encefalopatia pós-asfixia foram de 10 por 1.000, trazendo um risco potencial de seqüelas cerebrais posteriores 10 vezes maior do que na Europa Ocidental, por exemplo, onde esse nível de morbidade neurológica era encontrado no início da década de 70, antes da generalizaçäo da monitorizaçäo eletrônica fetal intraparto. Nossos resultados mostram que essa taxa de morbidade neurológica junto a uma mortalidade perinatal elevada (39,9 por cento) coexistem com uma freqüência alta de cesarianas (33,8 por cento), configurando padräo epidemiológico incomum na literatura internacional e questionando o valor deste percentual elevado de cirurgias