Prolonged ApneaPIANCT00482781
DTaP and Apnea/Bradycardia in Preterm Infants
A study testing Infanrix and Pediatrix in people with Prolonged Apnea and Prolonged Bradycardia, run by American SIDS Institute at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 56 to 60 days
- Conditions the study is for
- Prolonged Apnea, Prolonged Bradycardia
- What is being tested?
- Infanrix and Pediatrix
- How many people
- 191 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2000to Sep 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born at a gestational age < 37 weeks.
- Still in the hospital at time of study.
- Between 56 - 60 days chronological age.
Who cannot join
- Had active infections, were critically ill, or had unstable vital signs.
- Requiring assisted ventilation or tracheostomy during the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Wellstar Cobb Hospital
Austell, Georgia, 30106
St. Peters Univ. Hospital
Belle Mead, New Jersey, 08502
Brooklyn Hospital
Brooklyn, New York, 11201
Children's Hospital
Greenville, South Carolina, 29605
Kennestone Hospital
Marietta, Georgia, 30060
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
The Children's Home of Pittsburgh
Pittsburgh, Pennsylvania, 15232
St. Joseph's Hospital Health Ctr.
Syracuse, New York, 13203
Toledo Children's Hospital
Toledo, Ohio, 43606
About this study
Official title: 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.
Read the 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.
- Conditions
- Prolonged Apnea, Prolonged Bradycardia
- Being tested
- Infanrix, Pediatrix
- Keywords
- Apnea, Bradycardia, Preterm Infant, Immunization, DTaP
- Medical subject headings
- Apnea, Bradycardia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfanrixBiological
PediatrixBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six days (Three 48-hour periods).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startSep 2000
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- American SIDS Institute
- Sponsor type
- University, hospital or other
- Investigators
- Tracy Carbone, MD, Principal investigator, Valley Hospital, Ridgewood, NJBetty McEntire, PhD, Study director, American SIDS Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482781
- Sponsor's protocol ID
- PIA-09012000
- Acronym
- PIA
- Status last verified
- Jun 2007
- First submitted
- 1 Jun 2007
- Last updated
- 5 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18450851
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants: A Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT00482781
- Acronym / sponsor ID
- PIA / PIA-09012000
- Conditions
- Prolonged Apnea, Prolonged Bradycardia
- Keywords
- Apnea, Bradycardia, Preterm Infant, Immunization, DTaP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- American SIDS InstituteUniversity, hospital or other
- Study start
- Sep 2000
- Study completion
- Sep 2004 (actual)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 56 to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born at a gestational age < 37 weeks.
- Still in the hospital at time of study.
- Between 56 - 60 days chronological age.
Key exclusion criteria (2 listed)
- Had active infections, were critically ill, or had unstable vital signs.
- Requiring assisted ventilation or tracheostomy during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infanrix | Biological | – |
| Pediatrix | Biological | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2007.
- Derived from this study: PubMed 18450851Carbone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Carbone, MD principal investigator
Valley Hospital, Ridgewood, NJ
Betty McEntire, PhD study director
American SIDS Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infanrix and Pediatrix in people with Prolonged Apnea and Prolonged Bradycardia, run by American SIDS Institute at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00482781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2007.