An interventional study of Infanrix and Pediatrix in Prolonged Apnea and Prolonged Bradycardia, sponsored by American SIDS Institute. Completed at 10 sites in United States. Open to participants aged 56 Days to 60 Days. Per ClinicalTrials.gov, last updated 2007-06-05.
Sponsored by American SIDS Institute · Not applicable, Interventional, and Prevention
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 191 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →American SIDS Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bedside recording of apnea and bradycardia with events verified by 2 independent scorers who were blinded to the study phase and immunization status of the subject.
Time frame: Six days (Three 48-hour periods).
This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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American SIDS Institute