J Tripp

Environment of infants during sleep and risk of the sudden infant death syndrome: results of 1993-5 case-control study for confidential inquiry into stillbirths and deaths in infancy. Confidential Enquiry into Stillbirths and Deaths Regional Coordinators and Researchers.

Abstract Objective: To investigate the role of sleeping arrangements as risk factors for the sudden infant death syndrome after a national risk reduction campaign. Design: Two year population based case-control study. Parental interviews were conducted for each infant who died and for four controls matched for age and date of interview. Setting: Three regions in England with a total population of 17 million people. Subjects: 195 babies who died and 780 matched controls. Results: Prone and side sleeping positions both carried increased risks of death compared with supine when adjusted for maternal age, parity, gestation, birth weight, exposure to smoke, and other relevant factors in the sleeping environment (multivariate odds ratio = 9.00 (95% confidence interval 2.84 to 28.47) and 1.84 (1.02 to 3.31), respectively). The higher incidence of side rather than prone sleeping led to a higher population attributable risk (side 18.4%, prone 14.2%). More of the infants who died were found with bed covers over their heads (21.58; 6.21 to 74.99). The use of a dummy had an apparent protective effect (0.38; 0.21 to 0.70). Bed sharing for the whole night was a significant risk factor for infants whose mothers smoked (9.25; 2.31 to 34.02). No protective effect of breast feeding could be identified on multivariate analysis. Conclusions: This study confirms the importance of certain risk factors for the sudden infant death syndrome and identifies others—for example, covers over the head, side sleeping position—which may be amenable to change by educating and informing parents and health care professionals. Key messages This large case-control study is the first after the national campaign to reduce the risk of the syndrome The risk of sudden infant death is increased by prone or side sleeping position; loose bedding (particularly duvets), which can slip over the babys head; and bed sharing by mothers who smoke The risk may be reduced by supine sleeping position; placing the baby with feet at the foot of the cot (“feet to foot”); ensuring that bedding is securely tucked in; and avoiding the use of duvets

Smoking and the sudden infant death syndrome: results from 1993-5 case-control study for confidential inquiry into stillbirths and deaths in infancy

Abstract Objective: To investigate the effects of exposure to tobacco smoke and of parental consumption of alcohol and illegal drugs as risk factors for the sudden infant death syndrome after a national risk reduction campaign which included advice on prenatal and postnatal avoidance of tobacco smoke. Design: Two year population based case-control study. Parental interviews were conducted for each infant who died and four controls matched for age and date of interview. Setting: Three regions in England with a total population of 17 million people. Subjects: 195 babies who died and 780 matched controls. Results: More index than control mothers (62.6% v 25.1%) smoked during pregnancy (multivariate odds ratio = 2.10; 95% confidence interval 1.24 to 3.54). Paternal smoking had an additional independent effect when other factors were controlled for (2.50; 1.48 to 4.22). The risk of death rose with increasing postnatal exposure to tobacco smoke, which had an additive effect among those also exposed to maternal smoking during pregnancy (2.93; 1.56 to 5.48). The population attributable risk was over 61%, which implies that the numbers of deaths from the syndrome could be reduced by almost two third if parents did not smoke. Alcohol use was higher among index than control mothers but was strongly correlated with smoking and on multivariate analysis was not found to have any additional independent effect. Illegal drug use was more common among the index parents, and paternal use of illegal drugs remained significant in the multivariate model (4.68; 1.56 to 14.05). Conclusions: This study confirms the increased risk of the sudden infant death syndrome associated with maternal smoking during pregnancy and shows evidence that household exposure to tobacco smoke has an independent additive effect. Parental drug misuse has an additional small but significant effect. Key messages Exposure of babies to tobacco smoke from other members of the household before or after birth increases the risk of death: the greater the exposure the higher the risk Over 60% of such deaths may be attributable to the effects of exposure to tobacco smoke before and after birth

Haemorrhagic disease of the newborn in the British Isles : two year prospective study

OBJECTIVE--To determine the incidence of haemorrhagic disease of the newborn in the British Isles, study risk factors, and examine the effect of vitamin K prophylaxis. DESIGN--Prospective survey of all possible cases of haemorrhagic disease of the newborn as reported by consultant paediatricians using the monthly notification cards of the British Paediatric Surveillance Unit and a follow up questionnaire for each case to validate the diagnosis and accrue further data. SETTING--Britain (England, Scotland, and Wales) and Ireland (Northern Ireland and the Irish Republic) during December 1987 to March 1990. PATIENTS--27 infants classified as having confirmed (n = 25) or probable (n = 2) haemorrhagic disease of the newborn. RESULTS--24 of the 27 infants were solely breast fed. 10 suffered intracranial haemorrhage; two of these died and there was clinical concern about the remainder. 20 infants had received no vitamin K prophylaxis, and seven had received oral prophylaxis. Relative risk ratios for these groups compared with babies who had received intramuscular vitamin K were 81:1 and 13:1 respectively. Six infants had hepatitis (alpha 1 antitrypsin deficiency in four), unsuspected until presentation with haemorrhagic disease of the newborn, of whom four had received oral prophylaxis. One other baby had prolonged jaundice. One mother had taken phenytoin during pregnancy. CONCLUSIONS--All newborn infants should receive vitamin K prophylaxis. Intramuscular vitamin K is more effective than oral prophylactic regimens currently used in the British Isles.

The UK accelerated immunisation programme and sudden unexpected death in infancy: case-control study

Abstract Objectives: To investigate whether the accelerated immunisation programme in the United Kingdom is associated, after adjustment for potential confounding, with the sudden infant death syndrome. Design: Population based case-control study, February 1993 to March 1996. Parental interviews were conducted for each death and for four controls matched for age, locality, and time of sleep. Immunisation status was taken from records held by the parents. Setting: Five regions in England with a combined population of over 17 million. Subjects: Immunisation details were available for 93% (303/325) of infants whose deaths were attributed to the sudden infant death syndrome (SIDS); 90% (65/72) of infants with explained sudden deaths; and 95% (1515/1588) of controls. Results: After all potential confounding factors were controlled for, immunisation uptake was strongly associated with a lower risk of SIDS (odds ratio 0.45 (95% confidence interval 0.24 to 0.85)). This difference became non-significant (0.67 (0.31 to 1.43)) after further adjustment for other factors specific to the infants sleeping environment. Similar proportions of SIDS deaths and reference sleeps (corresponding to the time of day during which the index baby had died) among the controls occurred within 48 hours of the last vaccination (5% (7/149) v 5% (41/822)) and within two weeks (21% (31/149) v 27% (224/822)). No longer term temporal association with immunisation was found (P=0.78). Of the SIDS infants who died within two weeks of vaccination, 16% (5/31) had signs and symptoms of illness that suggested that medical contact was required, compared with 26% (16/61) of the non-immunised SIDS infants of similar age. The findings for the infants who died suddenly and unexpectedly but of explained causes mirrored those for SIDS infants. Conclusions: Immunisation does not lead to sudden unexpected death in infancy, and the direction of the relation is towards protection rather than risk. What is already known on this topic Some studies have suggested a link between the sudden infant death syndrome and primary immunisation, but most have failed to show a link Potential bias in the studies includes lack of a comparative control group with similar low immunisation uptake and misclassification of cause of death What this study adds This study investigated explained sudden infant deaths as well as the sudden infant death syndrome and took into account potential bias After confounding was controlled for, immunisation uptake was lowest among the infants who died, with no temporal relation or correlation with signs and symptoms of illness

Vitamin K deficiency bleeding in Great Britain and Ireland: British Paediatric Surveillance Unit Surveys, 1993–94 and 2001–02

Objective: To conduct and report monitoring of vitamin K deficiency bleeding (VKDB) in Great Britain and Ireland following the 1988–90 survey (VKDB-90). Design: Two 2-year surveys conducted during 1993–4 (VKDB-94) and 2001–02 (VKDB-02). Setting: Data collected from all consultant paediatricians in Great Britain and Ireland. Patients: All infants presenting with bleeding resulting from vitamin K (VK) deficiency. Main outcome measures: Incidence of VKDB, related mortality/morbidity and VK prophylaxis recommended/received, noting predisposing features. Results: Compared with previous studies, VKDB-02 found fewer cases of VKDB (RR: 0.27 (95% CI: 0.12 to 0.59), p<0.001) with no deaths, no long-term morbidity and reduced incidence among those receiving any oral dosing (RR: 0.24 (95% CI: 0.06 to 1.01), p<0.059). Breast-fed infants accounted for the vast majority of cases. The number receiving no prophylaxis fell consecutively over time: 20 of 27 in VKDB-90, 10 of 32 in VKDB-94 and 4 (because of parental refusal) of 7 in VKDB-02. Seven received one oral dose of VK in VKDB-90, 16 in VKDB-94 and none in VKDB-02. Underlying liver disease was found in six cases in VKDB-90, 12 in VKDB-94 and one in VKDB-02. Conclusions: In the most recent survey, the incidence of VKDB was about one third that in the two earlier studies. Late onset VKDB remains virtually confined to breast-fed infants who have received either no VK or just one oral dose. The effectiveness of oral prophylaxis regimens has improved over the last 15 years, but parental refusal of prophylaxis has become more problematic.

Neonatal vitamin K prophylaxis in Great Britain and Ireland: the impact of perceived risk and product licensing on effectiveness

Objective: To determine current use of vitamin K (VK) prophylaxis in newborns and review the efficacy and effectiveness of regimens used. Design: Efficacy and effectiveness calculated using current practice details, data from Southern Ireland and two previous surveys, together with contemporaneous studies of vitamin K deficiency bleeding (VKDB). Setting: Current survey: United Kingdom (Great Britain and Northern Ireland). Efficacy and effectiveness tables: United Kingdom and Southern Ireland. Main outcome measures: Current VK prophylaxis following uncomplicated term deliveries. Relative risk of VKDB calculated for the VK actually received and for “intention to treat”. Results: Questionnaire response rate 95% (n = 243), all recommending VK prophylaxis. No association between unit size and route of administration. For uncomplicated term deliveries, 60% recommended intramuscular (IM) prophylaxis, 24% oral and 16% offered both routes without bias. All units offering IM gave a single dose, mostly 1 mg Konakion Neonatal. Oral regimens showed more variation: two thirds gave 2 mg (range 0.5–2 mg), the number of doses ranged from 1 to 11 and many used preparations off-licence or the unlicensed Orakay. IM prophylaxis, if given, provided the best protection (most efficacious) against VKDB. However, on an intention-to-treat basis (effectiveness), there is no statistically significant difference between the risks of VKDB after intended IM VK and after oral prophylaxis intended to continue beyond a week. Conclusions: Although the principles of VK prophylaxis is now accepted by all, there is no uniformity in practice. Omission of prophylaxis appears to be a greater problem for IM than for multi-dose oral prophylaxis, affecting overall effectiveness.

Vitamin K deficiency bleeding after NICE guidance and withdrawal of Konakion Neonatal: British Paediatric Surveillance Unit study, 2006–2008

Objective To survey vitamin K deficiency bleeding (VKDB) and document vitamin K (VK) prophylaxis practice, and compare with findings predating withdrawal of Konakion Neonatal and guidance from the National Institute of Health and Clinical Excellence (NICE), both occurring in 2006. Design Two-year surveillance of VKDB (2006–2008) using British Paediatric Surveillance Unit methodology. Postal questionnaire to consultant-led maternity units. Setting UK and Irish Republic. Patients All newborns and infants under 6 months with suspected VKDB. Main outcome measures VKDB incidence and predisposing factors, VK prophylaxis recommended/received. Results Eleven cases of VKDB were found: six (55%) babies received no VK prophylaxis, in five (45.5%) because parents withheld consent; three (27.5%) babies with late VKDB received intramuscular (IM) Konakion MM (two had biliary atresia, and one was delivered preterm); two (18%) babies received incomplete oral prophylaxis. Nine babies (82%) were breast fed. Three (27%) babies had liver disease; four (36%), including all those with liver disease, were jaundiced at presentation after 21 days. Four (36%) babies had intracranial haemorrhage, two probably suffering long-term morbidity. VK prophylaxis practice was defined in 236 (100%) units. All units recommended prophylaxis for every newborn: 169 (72%) IM, 19 (8%) oral, and 48 (20%) offered parental choice. All units that recommended IM prophylaxis used Konakion MM. Oral prophylaxis always involved multidose regimens for breastfed babies; 61 (91%) units used Konakion MM, and six (9%) used unlicensed products suitable for administration by parents. Conclusions IM Konakion MM is efficacious, but parents withholding consent for recommended IM prophylaxis reduces effectiveness. Reappraisal of NICE guidance would be appropriate. Prolonged jaundice demands investigation. Late VKDB occasionally occurs after IM prophylaxis.

Diabetes and developing knowledge of the body.

Fifty seven diabetic children were compared with healthy children for knowledge of their bodies and causes of diabetes. Diabetic children were more likely to include the pancreas and less likely to include the brain or stomach in drawing their bodies. The data have implications for understanding how illness affects psychological development.

The vitamin K debacle: cut the Gordian knot

Editor,—In his letter1 about our annotation on vitamin K,2 Dr Williams questions the incidence quoted for vitamin K deficiency bleeding among babies given no prophylaxis. We thank him for drawing our attention to what was a typographical error [on our part]. The …

Vitamin K prophylaxis and vitamin K deficiency bleeding in the UK

Aim To correlate incidence, morbidity and mortality of vitamin K deficiency bleeding (VKDB) with changing practices in vitamin K (VK) prophylaxis in the UK—most recently the withdrawal of Konakion Neonatal in 2006, leaving Konakion MM as the only licenced preparation for prophylaxis in the UK. Method Since 1988 four 2-year studies of VKDB have been undertaken via the British Paediatric Surveillance Unit (BPSU), each with a contemporaneous survey of VK prophylaxis. The 2001–2002 survey preceded withdrawal of Konakion Neonatal, the 2006–2008 survey followed it. Results VKDB incidences in the two recent studies are not statistically different, but lower than previously. VK was recommended by all units in the two recent studies. In 1993–1994 only 38% of babies received intramuscular VK. By 2001–2002, 60% of units recommended intramuscular, most using Konakion Neonatal; by 2006–2008 72% of units recommended intramuscular, all using Konakion MM. In 1993–1994, 60% of babies were routinely offered oral prophylaxis, ending by day 7 in 25% of these. In 2001–2002 and 2006–2008 almost all used multiple-dose regimens extending to 28+ days in breastfed infants. Some parents withhold consent for any VK prophylaxis (50% of recent cases). The three cases of late VKDB associated with liver disease in 2006–2008 were jaundiced at presentation on day 23, 66 and 86; the first had oral, the others intramuscular VK. Long-term sequelae from intracranial haemorrhage are expected in one; another died of liver failure. Investigating prolonged jaundice was not routine in 10% of units responding (n=198 of total 236 units) Abstract G133 Table 1 BPSU study VKDB cases No VK Consent withheld Oral VK not beyond 7 days Multiple oral doses, beyond 7 days Intramuscular 1988–1990 27 20 Unknown 7 0 0 1993–1994 32 10 4 18 3 2 2001–2002 7 4 4 2 1 1 2006–2008 11 6 5 1* 1† 3 * Dose possibly not given till day 3; spat out. Bled before 2nd dose † Unit guideline not followed Abstract G133 Table 2 BPSU study Death from VKDB Intracranial haemorrhage Long-term morbidity Liver disease Breast fed 1988–1990 2 10 8 7 24 1993–1994 0 10 6 12 25 2001–2002 0 0 0 1 7 2006–2008 0* 4 2 3 9 * 1 death from liver failure Conclusions ▸ Most babies developing VKDB are breast-fed and have received no VK, usually because parents refuse it. Some 30% have unrecognised liver disease. ▸ Substituting Konakion MM for Konakion Neonatal has not been associated with a significant increase in VKDB incidence. ▸ Prophylaxis cannot alone prevent all cases. Early detection of liver disease by investigating prolonged jaundice identifies some of the most vulnerable babies before they bleed and may improve the prognosis of the underlying disease; all units should promote this practice.