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DTaP and Apnea/Bradycardia in Preterm Infants

NCT ID: NCT00482781

Last Updated: 2007-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2004-09-30

Brief Summary

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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

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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.

Conditions

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Prolonged Apnea Prolonged Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Infanrix

Intervention Type BIOLOGICAL

Pediatrix

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

56 Days

Maximum Eligible Age

60 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American SIDS Institute

OTHER

Sponsor Role lead

Principal Investigators

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Tracy Carbone, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Hospital, Ridgewood, NJ

Betty McEntire, PhD

Role: STUDY_DIRECTOR

American SIDS Institute

Locations

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Wellstar Cobb Hospital

Austell, Georgia, United States

Site Status

Kennestone Hospital

Marietta, Georgia, United States

Site Status

St. Peters Univ. Hospital

Belle Mead, New Jersey, United States

Site Status

Brooklyn Hospital

Brooklyn, New York, United States

Site Status

St. Joseph's Hospital Health Ctr.

Syracuse, New York, United States

Site Status

Toledo Children's Hospital

Toledo, Ohio, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Site Status

The Children's Home of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Children's Hospital

Greenville, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18450851 (View on PubMed)

Other Identifiers

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PIA-09012000

Identifier Type: -

Identifier Source: org_study_id