Prolonged Apnea Clinical Trial
Official title:
Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants: A Randomized Multicenter Study
The purpose of this study is to examine the relationship between receipt of DTaP and the occurrence of prolonged episodes of apnea and bradycardia in preterm infants, while employing a random control study design and an objective assessment of cardiorespiratory events.
The American Academy of Pediatrics (AAP) recommends the immunization of preterm infants at
two months chronological age with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine,
regardless of birth weight and gestational age. However, several investigators, employing
historical controls and subjective observations, have reported an increased incidence in
prolonged apnea and bradycardia in preterm infants following immunization. Consequently,
many primary care providers do not adhere to recommended AAP guidelines. The purpose of this
study is to reexamine the relationship between receipt of DTaP and the occurrence of
prolonged episodes of apnea and bradycardia in preterm infants, while employing a random
control study design and an objective assessment of cardiorespiratory events.
Ten participating hospitals will enroll infants < 37 completed weeks gestational age into
the study when they are 56-60 days chronological age. Infants are randomly assigned into one
of two groups: One group receives DTaP immunization and the control group does not (until
study is completed). Physiological event recording monitors are used continuously during the
next 2 days to document the incidence of prolonged apnea (respiratory pause of ≥20 sec in
duration or >15 sec in duration if associated with bradycardia for ≥5 sec) and prolonged
bradycardia (heart rate <80 bpm that lasted ≥10 sec) in all infants. The presence and number
of episodes during the 48-hour period will be compared between the 2 groups.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention