Clinical trial NCT00482781: DTaP and Apnea/Bradycardia in Preterm Infants
Official title: Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants: A Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Apnea
Prolonged Bradycardia
Keywords: Apnea
Bradycardia
Preterm Infant
Immunization
DTaP
Lead sponsor: American SIDS Institute
Sponsor class: OTHER
First posted: 2007-06-05
Enrollment: 191
Sex: ALL
Minimum age (years): 56
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Six days (Three 48-hour periods).
Secondary outcomes:
Other outcomes:
Locations:
city: Austell
country: United States
facility: Wellstar Cobb Hospital
state: Georgia
city: Marietta
country: United States
facility: Kennestone Hospital
state: Georgia
city: Belle Mead
country: United States
facility: St. Peters Univ. Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Hospital
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Ctr.
state: New York
city: Toledo
country: United States
facility: Toledo Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Children's Home of Pittsburgh
state: Pennsylvania
city: Greenville
country: United States
facility: Children's Hospital
state: South Carolina
Study officials:
affiliation: Valley Hospital, Ridgewood, NJ
name: Tracy Carbone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: American SIDS Institute
name: Betty McEntire, PhD
role: STUDY_DIRECTOR
References:
citation: 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.