Abstract
BackgroundAdverse cardiorespiratory events including apnea, bradycardia, and desaturations have been described following administration of the first diphtheria-tetanus-pertussis-inactivated polio-Haemophilus influenzae type B (DTP-IPV-Hib) immunization to preterm infants. The effect of the recent substitution of acellular pertussis vaccine for whole cell pertussis vaccine on the frequency of these events requires further study.MethodsInfants with gestational age of ≤ 32 weeks who received their first DTP-IPV-Hib immunization prior to discharge from two Edmonton Neonatal Intensive Care Units January 1, 1996 to November 30, 2000 were eligible for the study. Each immunized infant was matched by gestational age to one control infant. The number of episodes of apnea, bradycardia, and/or desaturations (ABD) and the treatment required for these episodes in the 72 hours prior to and 72 hours post-immunization (for the immunized cohort) or at the same post-natal age (for controls) was recorded.ResultsThirty-four infants who received DTP-IPV-Hib with whole cell pertussis vaccine, 90 infants who received DTP-IPV-Hib with acellular pertussis vaccine, and 124 control infants were entered in the study. Fifty-six immunized infants (45.1%) and 36 control infants (29.0%) had a resurgence of or increased ABD in the 72 hours post-immunization in the immunized infants and at the same post-natal age in the controls with an adjusted odds ratio for immunized infants of 2.41 (95% CI 1.29,4.51) as compared to control infants. The incidence of an increase in adverse cardiorespiratory events post-immunization was the same in infants receiving whole cell or acellular pertussis vaccine (44.1% versus 45.6%). Eighteen immunized infants (14.5%) and 51 control infants (41.1%) had a reduction in ABD in the 72 hours post- immunization or at the equivalent postnatal age in controls for an odds ratio of 0.175 (95%CI 0.08, 0.39). The need for therapy of ABD in the immunized infants was not statistically different from the control infants. Lower weight at the time of immunization was a risk factor for a resurgence of or increased ABD post-immunization. Birth weight, gestational age, postnatal age or sex were not risk factors.ConclusionThere is an increase in adverse cardiorespiratory events following the first dose of DTP-IPV-Hib in preterm infants. Lower current weight was identified as a risk factor, with the risk being equivalent for whole cell versus acellular pertussis vaccine. Although most of these events are of limited clinical significance, cardiorespiratory monitoring of infants who are sufficiently preterm that they are receiving their first immunization prior to hospital discharge should be considered for 72 hours post-immunization.
Highlights
Adverse cardiorespiratory events including apnea, bradycardia, and desaturations have been described following administration of the first diphtheria-tetanus-pertussis-inactivated polioHaemophilus influenzae type B (DTP-IPV-Hib) immunization to preterm infants
In multiple previous studies, a 7 to 47% incidence of adverse cardiorespiratory events including apnea, bradycardia, and/or desaturation (ABD) has been reported following the first diphtheriatetanus-pertussis-inactivated polio-Haemophilus influenzae type B (DTP-IPV-Hib) immunization of preterm infants [2-10], with the most common theory being that these events are precipitated by the whole cell pertussis component of the vaccine [3]
DTP-IPV-Hib with whole cell pertussis vaccine was used prior to July 1, 1997 and DTP-IPV-Hib with acellular pertussis vaccine was used starting on this date
Summary
Adverse cardiorespiratory events including apnea, bradycardia, and desaturations have been described following administration of the first diphtheria-tetanus-pertussis-inactivated polioHaemophilus influenzae type B (DTP-IPV-Hib) immunization to preterm infants. In multiple previous studies, a 7 to 47% incidence of adverse cardiorespiratory events including apnea, bradycardia, and/or desaturation (ABD) has been reported following the first diphtheriatetanus-pertussis-inactivated polio-Haemophilus influenzae type B (DTP-IPV-Hib) immunization of preterm infants [2-10], with the most common theory being that these events are precipitated by the whole cell pertussis component of the vaccine [3]. A retrospective stratified cohort study was completed to determine the frequency of adverse cardiorespiratory events among premature infants following their first immunization with DTP-IPV-Hib vaccine and to compare the frequency of events following whole cell versus acellular pertussis vaccines. A further objective was to study possible risk factors for these adverse events
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