DTaP and Apnea/Bradycardia in Preterm Infants (PIA)

This study has been completed.
Sponsor:
Information provided by:
American SIDS Institute
ClinicalTrials.gov Identifier:
NCT00482781
First received: June 1, 2007
Last updated: June 4, 2007
Last verified: June 2007
  Purpose

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: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants: A Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by American SIDS Institute:

Primary Outcome Measures:
  • 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). ]

Enrollment: 191
Study Start Date: September 2000
Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   56 Days to 60 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482781

Locations
United States, Georgia
Wellstar Cobb Hospital
Austell, Georgia, United States, 30106
Kennestone Hospital
Marietta, Georgia, United States, 30060
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
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
The Children's Home of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Children’s Hospital
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
American SIDS Institute
Investigators
Principal Investigator: Tracy Carbone, MD Valley Hospital, Ridgewood, NJ
Study Director: Betty McEntire, PhD American SIDS Institute
  More Information

No publications provided by American SIDS Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00482781     History of Changes
Other Study ID Numbers: PIA-09012000
Study First Received: June 1, 2007
Last Updated: June 4, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by American SIDS Institute:
Apnea
Bradycardia
Preterm Infant
Immunization
DTaP

Additional relevant MeSH terms:
Apnea
Bradycardia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 20, 2014