DTaP and Apnea/Bradycardia in Preterm Infants (PIA)

June 4, 2007 updated by: American SIDS Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Austell, Georgia, United States, 30106
        • WellStar Cobb Hospital
      • Marietta, Georgia, United States, 30060
        • Kennestone Hospital
    • New Jersey
      • Belle Mead, New Jersey, United States, 08502
        • St. Peters Univ. Hospital
    • New York
      • Brooklyn, New York, United States, 11201
        • Brooklyn Hospital
      • Syracuse, New York, United States, 13203
        • St. Joseph's Hospital Health Ctr.
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Toledo Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • The Children's Home of Pittsburgh
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Six days (Three 48-hour periods).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American SIDS Institute

Investigators

  • Principal Investigator: Tracy Carbone, MD, Valley Hospital, Ridgewood, NJ
  • Study Director: Betty McEntire, PhD, American SIDS Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

June 1, 2007

First Submitted That Met QC Criteria

June 4, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Estimate)

June 5, 2007

Last Update Submitted That Met QC Criteria

June 4, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIA-09012000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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