DTaP and Apnea/Bradycardia in Preterm Infants

Prolonged Apnea Clinical Trial

— PIA  

Official title:

Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants: A Randomized Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482781
• Other study ID #: PIA-09012000
• Status: Completed
• Phase: N/A
• First received: June 1, 2007
• Last updated: June 4, 2007
• Start date: September 2000
• Est. completion date: September 2004

Study information

• Verified date: June 2007
• Source: American SIDS Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Days to 60 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Bradycardia
• Prolonged Apnea
• Prolonged Bradycardia

Intervention

Biological:
• Infanrix

• Pediatrix

Locations

Country	Name	City	State
United States	Wellstar Cobb Hospital	Austell	Georgia
United States	St. Peters Univ. Hospital	Belle Mead	New Jersey
United States	Brooklyn Hospital	Brooklyn	New York
United States	Children’s Hospital	Greenville	South Carolina
United States	Kennestone Hospital	Marietta	Georgia
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	The Children's Home of Pittsburgh	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	St. Joseph's Hospital Health Ctr.	Syracuse	New York
United States	Toledo Children's Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
American SIDS Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).