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DTaP and Apnea/Bradycardia in Preterm Infants (PIA)

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ClinicalTrials.gov Identifier: NCT00482781
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : June 5, 2007
Sponsor:
Information provided by:

June 1, 2007
June 5, 2007
June 5, 2007
September 2000
Not Provided
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). ]
Same as current
No Changes Posted
Not Provided
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DTaP and Apnea/Bradycardia in Preterm Infants
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
  • Prolonged Apnea
  • Prolonged Bradycardia
  • Biological: Infanrix
  • Biological: Pediatrix
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
191
September 2004
Not Provided

Inclusion Criteria:

  • Born at a gestational age < 37 weeks.
  • Still in the hospital at time of study.
  • Between 56 - 60 days chronological age.

Exclusion Criteria:

  • Had active infections, were critically ill, or had unstable vital signs.
  • Requiring assisted ventilation or tracheostomy during the study.
Sexes Eligible for Study: All
56 Days to 60 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00482781
PIA-09012000
No
Not Provided
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Not Provided
American SIDS Institute
Not Provided
Principal Investigator: Tracy Carbone, MD Valley Hospital, Ridgewood, NJ
Study Director: Betty McEntire, PhD American SIDS Institute
American SIDS Institute
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP