80 research outputs found
Screening for congenital hypothyroidism in the Netherlands
Screening provides a means for 11filtering disease from the population11,
until then unrecognized by patient or physician. In an increasing
number of diseases, early detection is helpful in preventing
serious consequences, by treatment or by genetic counseling on the
recurrence risk of congenital disorders.
New developments in the early detection of genetic metabolic diseases
and other congenital disorders, which are a frequent cause of
infant morbidity and mortality, have proceeded rapidly during the
last decades (see Galjaard, 1980). Neonatal screening is one of
these developments and contributes to the improvement of the prognosis
of several diseases in early infancy. Screening for phenylketonuria
is, at present, a common procedure in many countries. Other
diseases such as maple syrup urine disease, homocystinuria, histidinemia,
galactosemia and congenital hypothyroidism (CHT), have been
recommended as suitable for screening or have already been included
in existing programs (Levy, 1973; Bickel et al., 1980).
This study deals with the institution of neonatal screening for CHT
in the Netherlands. Screening for this disorder was first introduced
in some North American areas in 1974 and, from then on, also in many
other countries, either in the form of trial studies or nation-wide,
and mostly in combination with the existing PKU programs (Newborn
Committee of the European Thyroid Association, 1979; Fisher et al.,
1979). In the Netherlands, PKU screening was introduced on a nationwide
scale in 1974. In the following year, the Government asked the
Health Council (a governmental advisory board) for advice on the
need for extension of the PKU screening program with other early detection
methods for congenital disorders. To come to a decision, the
Health Council took into consideration, among other things, the frequency
and the severeness of the congenital disorders, and the possi-·
bil ities for diagnosis and treatment at the time of neonatal screening
in our country; only screening for CHT met the criteria posed
(Gezondheidsraad, 1980)
Randomized, controlled trial of ibuprofen syrup administered during febrile illnesses to prevent febrile seizure recurrences
OBJECTIVES: Febrile seizures recur frequently. Factors increasing the risk
of febrile seizure recurrence include young age at onset, family history
of febrile seizures, previous recurrent febrile seizures, time lapse since
previous seizure <6 months, relative low temperature at the initial
seizure, multiple type initial seizure, and frequent febrile illnesses.
Prevention of seizure recurrences serves two useful purposes: meeting
parental fear of recurrent febrile seizures in general and reducing the
(small) risk of a long-lasting and eventually injurious recurrent seizure.
In daily practice, children with febrile seizures often are treated with
antipyretics during fever to prevent febrile seizure recurrences. Thus
far, no randomized placebo-controlled trial has been performed to assess
the efficacy of intermittent antipyretic treatment in the prevention of
seizure recurrence. METHODS: We performed a randomized, double-blind,
placebo-controlled trial. Children 1 to 4 years of age who had had at
least one risk factor for febrile seizure recurrence were enrolled. They
were randomly assigned to either ibuprofen syrup, 20 mg/mL, 0.25 mL (= 5
mg) per kilogram of body weight per dose, or matching placebo, to be
administered every 6 hours during fever (temperature, >/=38.5 degrees C).
Parents were instructed to take the child's rectal temperature immediately
when the child seemed ill or feverish and to promptly administer the study
medication when the temperature was >/=38.5 degrees C. Doses were to be
administered every 6 hours until the child was afebrile for 24 hours. The
parents were instructed not to administer any other antipyretic drug to
the child. For measuring rectal temperature, a Philips HP5316 digital
thermometer (Philips, Eindhoven, The Netherlands) was distributed. During
subsequent treatment of the fever episode, parents had to call the
investigator at least once each day to notify the investigator in case of
febrile seizure recurrence. The investigator could be contacted by parents
24 hours per day. The primary outcome was the first recurrence of a
febrile seizure. Kaplan-Meier curves and Cox regression were used for the
statistical analysis. The treatment effect on the course of the
temperature was assessed using analysis of covariance, with temperature at
fever onset as covariate. Two analyses were performed. In an
intention-to-treat analysis, all first recurrences were considered
regardless of study medication compliance. A per-protocol analysis was
limited to those recurrences that occurred in the context of study
medication compliance. RESULTS: Between October 1, 1994, and April 1,
1996, 230 children were randomly assigned to ibuprofen syrup (111
children) or placebo (119 children). Median follow-up time was 1.04 years
(25th-75th percentiles; 0.7-1.8 years) in the ibuprofen group and 0.98
years (0.7-1.6 years) in the placebo group. Of all children, 67 had a
first febrile seizure recurrence, with 31 in the ibuprofen group and 36 in
the placebo group. The 2-year recurrence probabilities were 32% and 39%,
Frequency of fever episodes related to febrile seizure recurrence
The aim of this study was to assess the number of fever episodes as a risk factor for febrile seizure recurrence during the first 6 months after the last previous febrile seizure. In a 6-month follow-up study of 155 children, aged 3 months to 5 y, with a first or a recurrent febrile seizure, the occurrence of fever episodes and febrile seizure recurrences was prospectively documented. Using logistic regression analysis the association between the baseline characteristics and the number of fever episodes and the outcome, a febrile seizure recurrence, was studied. In total, 260 fever episodes were registered; 29 children experienced 1 or more febrile seizure recurrence during follow-up. Two factors were associated with febrile seizure recurrence: the number of fever episodes [odds ratio (OR)= 1.8; 95% confidence interval (CI): 1.4-2.4)] and age at study entry (OR=0.6; 95% CI: 0.3-1.1). In a multivariable model, only the number of fever episodes remained significant. In conclusion, the number of fever episodes increases the risk of a febrile seizure recurrence with a factor of 1.8 per fever episode in the first 6 months after a febrile seizure
Informed consent, parental awareness, and reasons for participating in a randomised controlled study
BACKGROUND: The informed consent procedure plays a central role in
randomised controlled trials but has only been explored in a few studies
on children. AIM: To assess the quality of the informed consent process in
a paediatric setting. METHODS: A questionnaire was sent to parents who
volunteered their child (230 children) for a randomised, double blind,
placebo controlled trial of ibuprofen syrup to prevent recurrent febrile
seizures. RESULTS: 181 (79%) parents responded. On average, 73% of parents
were aware of the major study characteristics. A few had difficulty
understanding the information provided. Major factors in parents granting
approval were the contribution to clinical science (51%) and benefit to
the child (32%). Sociodemographic status did not influence initial
participation but west European origin of the father was associated with
willingness to participate in future trials. 89% of participants felt
positive about the informed consent procedure; however, 25% stated that
they felt obliged to participate. Although their reasons for granting
approval and their evaluation of the informed consent procedure did not
differ, relatively more were hesitant about participating in future.
Parents appreciated the investigator being on call 24 hours a day (38%)
and the extra medical care and information provided (37%) as advantages of
participation. Disadvantages were mainly the time consuming aspects and
the work involved (23%). CONCLUSIONS: Parents' understanding of trial
characteristics might be improved by designing less difficult informed
consent forms and by the investigator giving extra attention and
information to non-west European parents. Adequate measures should be
taken to avoid parents feeling obliged to participate, rather than giving
true informed consent
- …