A total of 101 preterm infants between 26 and 37 weeks' gestation who received BCG vaccination at birth were evaluated between two and four months after vaccination. Altogether 32% of these infants had no visible BCG scar. The efficacy of BCG vaccination and its protection against tuberculosis in the full term infant after birth has been shown by several studies.'-3 BCG vaccination is recommended by the World Health Organisation for control of the disease in countries with a high incidence of tuberculosis.4 This policy is not routinely applied in preterm infants who may be at greater risk of infection than term infants. To the best of our knowledge there are no data on the effectiveness of BCG vaccination in preterm infants of less than 32 weeks' gestation and similar information on preterm babies of more than 32 weeks is limited.5The purpose of this study was to evaluate the effectiveness of giving BCG vaccination to preterm infants by looking at the following criteria.(1) The percentage of negative scars.(2) The percentage of tuberculin conversion between two and four months later. (3) The number of complications of the vaccination.
Familial glucocorticoid deficiency (FGD) is a rare autosomal recessive disorder characterized by glucocorticoid deficiency, elevated plasma adrenocorticotropic hormone (ACTH) levels and preserved aldosterone/renin secretion. Adrenocorticotropic receptor mutations occur in about 40% of patients (FGD type 1), whereas the rest of the cases are associated with a normal receptor (FGD type 2). More than 50 cases have been reported in the literature so far. We report two cases of type 2 FGD from two related families who presented in the newborn period with varying clinical features. Direct sequencing of the genomic DNA of the patients failed to reveal mutations or other defects in the coding sequence of the ACTH receptor. Linkage analysis excluded mutations on the MC2-R gene outside the coding region. To our knowledge, these are the first two cases of FGD reported from the Middle East.
Objectives: To investigate the recollections of parents consenting for their infants to be research subjects and determine their views about the need for consent. Subjects: Parents of 154 sick newborn infants enrolled in a randomised trial in the early neonatal period. All parents had given written consent and received printed information. Methods: A questionnaire and accompanying letter was sent to the parental home 18 months later. Nonresponders were sent a further questionnaire and letter. Results: Response rate was 64% (99/154). Some respondents (12%) did not remember being asked to consent to their baby joining a study, and a further 6% were unsure. Most of the respondents (79%) were happy, 13% neutral, and 8% unhappy with their decision to give consent. None felt heavy pressure to agree. Entering the trial caused 24% of respondents to feel more anxious, 56% neutral, and 20% less anxious about their baby. Most of the respondents (83%) would be unhappy to forgo the consent process for trials passed by the institutional ethics committee. Conclusions: A significant proportion of parents who give written consent for a trial in the early neonatal period do not later remember having done so. Parents who have had experience of neonatal research would be unhappy for their baby to be enrolled in a study that had ethics committee approval without their consent being obtained. W ritten consent from someone with parental responsibility is generally required before any child is enrolled in a clinical trial. Although it may safeguard the child's best interests, it is associated with many difficulties. Concern is expressed about the additional stress placed on parents.1 The ability of parents to process information and make informed decisions under these circumstances is questioned.2 Alternatives to the consent process have been proposed, 3 4 but these may be unacceptable to the parents whose consent would otherwise be sought.5 Serious concerns about the integrity of the consent process may be raised later, based on individual recollections.6 7 There are few data on the experiences of real parents who have been approached for consent. Snowdon et al 8 interviewed the parents of 21 infants who were enrolled in the ECMO trial.
9They found that some were unsure whether their babies were in a trial or not. In the Euricon study, 10 five of 200 parents could not remember being asked to give consent for a trial. We aimed to determine from parents whether they remembered being asked to give consent for a research study and how they felt the research had affected their experience as parents of a sick infant.
PATIENTS AND METHODSThe subjects were the parents of 199 infants entered into a randomised controlled trial of pulmonary function testing which was conducted in the Simpson Memorial Maternity Pavilion, Edinburgh between August 1991 and June 1993. 11 In all cases the parents were given a printed information sheet and a detailed verbal description of the trial by a single individual (BS). Whenever possible, both parents were...
Two hundred and sixty‐seven children with cancer who were autopsied in Texas Children's Hospital, between 1954–1969, have been retrospectively studied for Pneumocystis carinii pneumonia. Out of 267 cases, 15 patients (5.6%) with Pneumocystis infection were found. The number varied from 0 to 3 cases in different years with no increase in Pneumocystis infection in the last few years in contrast with reports from other centers. Infection is usually extensive but may consist of a few isolated organisms without an associated inflammatory response.
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