Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482781
Status:
COMPLETED
Last Update Posted:
2007-06-05
First Post:
2007-06-01
Brief Title:
DTaP and ApneaBradycardia in Preterm Infants
Sponsor:
American SIDS Institute
Organization:
American SIDS Institute
Study Overview
Official Title:
Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants A Randomized Multicenter Study
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIA
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None