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DTaP and Apnea/Bradycardia in Preterm Infants

NCT00482781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2007-06-05

No results posted yet for this study

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.

Conditions

  • Prolonged Apnea
  • Prolonged Bradycardia

Interventions

BIOLOGICAL

Infanrix

BIOLOGICAL

Pediatrix

Sponsors & Collaborators

  • American SIDS Institute

    lead OTHER

Principal Investigators

  • Tracy Carbone, MD · Valley Hospital, Ridgewood, NJ

  • Betty McEntire, PhD · American SIDS Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
56 Days
Max Age
60 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Completion
2004-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00482781 on ClinicalTrials.gov