We report on a liveborn premature male with trisomy 22 who had multiple congenital anomalies, including congenital diaphragmatic hernia and absence of corpus callosum. He died of pulmonary hypoplasia associated with diaphragmatic hernia within 12 hours of age. Chromosome analysis by multiple banding techniques based on lymphocyte culture confirmed that he had trisomy 22. This may be the first report of congenital diaphragmatic hernia and isolated absence of corpus callosum associated with trisomy 22.
Percutaneously inserted Silastic central venous catheters have been used for prolonged infusion of parenteral nutrition in neonates. Malassezia furfur infection has been associated with intravenous fat emulsions infused through central venous lines. In this paper, we report two premature infants whose Silastic catheters were adhered to the vein wall with associated M furfur infection.
Whether the traditional definition of small for gestational age (SGA) is an appropriate marker of risk for populations that have relatively lower birthweight is unclear. We determined proportions of White and Asian Indian SGA infants and those admitted to the special care nursery. Compared with White infants, Asian Indian infants were more likely to be SGA (14.5% versus 2.7%) and more likely to be admitted to the special care nursery (20.7% versus 3.7%), suggesting that traditional definitions of SGA may be applicable as a marker of risk.
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...
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