DTaP and Apnea/Bradycardia in Preterm Infants
PIA
Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants: A Randomized Multicenter Study
1 other identifier
interventional
191
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2000
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 1, 2007
CompletedFirst Posted
Study publicly available on registry
June 5, 2007
CompletedJune 5, 2007
June 1, 2007
June 1, 2007
June 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Six days (Three 48-hour periods).
Interventions
Eligibility Criteria
You may qualify if:
- Born at a gestational age \< 37 weeks.
- Still in the hospital at time of study.
- Between 56 - 60 days chronological age.
You may not qualify if:
- Had active infections, were critically ill, or had unstable vital signs.
- Requiring assisted ventilation or tracheostomy during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Wellstar Cobb Hospital
Austell, Georgia, 30106, United States
Kennestone Hospital
Marietta, Georgia, 30060, United States
St. Peters Univ. Hospital
Belle Mead, New Jersey, 08502, United States
Brooklyn Hospital
Brooklyn, New York, 11201, United States
St. Joseph's Hospital Health Ctr.
Syracuse, New York, 13203, United States
Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
The Children's Home of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Children's Hospital
Greenville, South Carolina, 29605, United States
Related Publications (1)
Carbone T, McEntire B, Kissin D, Kelly D, Steinschneider A, Violaris K, Karamchandani N. Absence of an increase in cardiorespiratory events after diphtheria-tetanus-acellular pertussis immunization in preterm infants: a randomized, multicenter study. Pediatrics. 2008 May;121(5):e1085-90. doi: 10.1542/peds.2007-2059.
PMID: 18450851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy Carbone, MD
Valley Hospital, Ridgewood, NJ
- STUDY DIRECTOR
Betty McEntire, PhD
American SIDS Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 1, 2007
First Posted
June 5, 2007
Study Start
September 1, 2000
Study Completion
September 1, 2004
Last Updated
June 5, 2007
Record last verified: 2007-06