PIA: DTaP and Apnea/Bradycardia in Preterm Infants

Sponsor

American SIDS Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00482781

Collaborator

(none)

191

Enrollment

Locations

Duration (Months)

19.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prolonged Apnea Prolonged Bradycardia	Biological: Infanrix Biological: Pediatrix	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

191 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2000

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

56 Days to 60 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wellstar Cobb Hospital	Austell	Georgia	United States	30106
2	Kennestone Hospital	Marietta	Georgia	United States	30060
3	St. Peters Univ. Hospital	Belle Mead	New Jersey	United States	08502
4	Brooklyn Hospital	Brooklyn	New York	United States	11201
5	St. Joseph's Hospital Health Ctr.	Syracuse	New York	United States	13203
6	Toledo Children's Hospital	Toledo	Ohio	United States	43606
7	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
8	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
9	The Children's Home of Pittsburgh	Pittsburgh	Pennsylvania	United States	15232
10	Children's Hospital	Greenville	South Carolina	United States	29605