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Sponsored by: |
American SIDS Institute |
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Information provided by: | American SIDS Institute |
ClinicalTrials.gov Identifier: | NCT00482781 |
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.
Condition | Intervention |
---|---|
Prolonged Apnea Prolonged Bradycardia |
Biological: Infanrix Biological: Pediatrix |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants: A Randomized Multicenter Study |
Enrollment: | 191 |
Study Start Date: | September 2000 |
Study Completion Date: | September 2004 |
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.
Ages Eligible for Study: | 56 Days to 60 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Kennestone Hospital | |
Marietta, Georgia, United States, 30060 | |
Wellstar Cobb Hospital | |
Austell, Georgia, United States, 30106 | |
United States, New Jersey | |
St. Peters Univ. Hospital | |
Belle Mead, New Jersey, United States, 08502 | |
United States, New York | |
Brooklyn Hospital | |
Brooklyn, New York, United States, 11201 | |
St. Joseph's Hospital Health Ctr. | |
Syracuse, New York, United States, 13203 | |
United States, Ohio | |
Toledo Children's Hospital | |
Toledo, Ohio, United States, 43606 | |
United States, Pennsylvania | |
The Children's Home of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15232 | |
Western Pennsylvania Hospital | |
Pittsburgh, Pennsylvania, United States, 15224 | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, South Carolina | |
Children’s Hospital | |
Greenville, South Carolina, United States, 29605 |
Principal Investigator: | Tracy Carbone, MD | Valley Hospital, Ridgewood, NJ |
Study Director: | Betty McEntire, PhD | American SIDS Institute |
Study ID Numbers: | PIA-09012000 |
Study First Received: | June 1, 2007 |
Last Updated: | June 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00482781 |
Health Authority: | United States: Institutional Review Board |
Apnea Bradycardia Preterm Infant Immunization DTaP |
Signs and Symptoms Heart Diseases Respiratory Tract Diseases Apnea |
Respiration Disorders Bradycardia Signs and Symptoms, Respiratory Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |