ALTENCT02779062
Apparent Life Threatening Events in Infants
An observational study of ALTE, run by NYU Langone Health at 1 site in United States.
Trial summary
Infants sometimes experience sudden symptoms such as breathing irregularities or limpness that frighten parents and prompt them to seek emergency medical care. While few of these episodes are truly life-threatening and require hospital admission, some parents may have been so frightened that they will resist returning… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALTE
- What is being tested?
- Interview
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult parents of infants with an apparent life threatening event
Who may be able to join
- Adult parents of an infant with an ALTE event
Who cannot join
- Unwilling to sign informed consent document
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: ALTE Study: Interviews With Parents of Infants Seen in an Emergency Department
Infants sometimes experience sudden symptoms such as breathing irregularities or limpness that frighten parents and prompt them to seek emergency medical care. While few of these episodes are truly life-threatening and require hospital admission, some parents may have been so frightened that they will resist returning home from the emergency department with their baby even if the objective risk is extremely small. Study subjects (parents of infants with an apparent life threatening event) will be contacted and interviewed. Investigators want to learn whether or not study subjects would accept returning home after a brief period of observation in the emergency department if the physician determines that it is safe to do so.
Read the detailed description
An apparent life-threatening event (ALTE) refers to the sudden occurrence in an infant of symptoms such as breathing irregularities, stiffness, or limpness, that appear frightening to caretakers, prompting them to seek medical care. ALTE was first defined in 1986 by an NIH consensus panel. Population-based epidemiologic studies have reported a range of 2.5 to 9.4 ALTE admissions per 1000 live births.
While few ALTEs are truly life-threatening, both clinicians and parents may assume that the infant's life was-and may still be-in danger until proven otherwise. Since the actual risk of an adverse outcome in a well-appearing ALTE patient is unknown, this concern often leads to an extensive diagnostic evaluation and hospitalization to rule out serious occult pathology even when a patient appears well on presentation and has an unremarkable clinical assessment.
Nonspecific inpatient diagnostic evaluations can harm patients by causing complications from invasive testing, false-positive test results, and vulnerable child syndrome. Given these risks and the low probability that such testing will identify a treatable diagnosis in a well-appearing infant, the American Academy of Pediatrics has established a Guideline Committee on ALTEs to develop recommendations for the management of these patients. Specifically, the Committee is formulating criteria to define a low-risk group of infants presenting with ALTE who may be safely discharged after minimal diagnostic testing and a few hours of observation. While an evidence-based clinical guideline has the potential to reduce unnecessary testing and hospital admissions, anecdotal evidence suggests that some parents may have been so frightened by the event that they will resist returning home with their baby even if the objective risk is extremely small. To gather data about parental attitudes, the investigators propose to survey subjects (parents of infants who have experienced an ALTE) to learn whether or not they would accept returning home after a brief period of observation in the emergency department if the physician determines that it is safe to do so. This survey will focus on subject's willingness to forgo admission to the hospital when the risks associated with hospitalization (e.g., hospital-acquired infection, complications of invasive diagnostic procedures) might outweigh the risk of a recurrent ALTE or serious underlying condition. Subject's with an obvious need for admission based on the initial clinical assessment will be excluded, since discharge home would not be an option. Study findings will inform efforts to develop clinical guidelines for the management of an ALTE that take into account both parental attitudes and objective evidence. Without both types of data, implementation of such a guideline will be problematic.
- Conditions
- ALTE
- Being tested
- Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interview
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental comfort level with disposition home from emergency department
Subject response (yes or no) to the following question: Would you have felt comfortable returning home from the emergency department with your baby (rather than admitting baby to the hospital overnight) if the medical evaluation in the emergency department had determined that it would be safe to do so? This question will be asked within the context of a series of questions addressing the subject's experience following the apparent life-threatening event of their infant.
Measured: Subject will be asked to describe their experiences in the ER when their infant was undergoing an evaluation following an apparent life-threatening event. Subject will be interviewed face-to-face or by telephone within 3 years of the event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALTEStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779062
- Sponsor's protocol ID
- 14030
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2016
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALTE Study: Interviews With Parents of Infants Seen in an Emergency Department
- ClinicalTrials.gov ID
- NCT02779062
- Acronym / sponsor ID
- 14030
- Conditions
- ALTE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 May 2016 (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.
Infants sometimes experience sudden symptoms such as breathing irregularities or limpness that frighten parents and prompt them to seek emergency medical care. While few of these episodes are truly life-threatening and require hospital admission, some parents may have been so frightened that they will resist returning home from the emergency department with their baby even if the objective risk is extremely small. Study subjects (parents of infants with an apparent life threatening event) will be contacted and interviewed. Investigators want to learn whether or not study subjects would accept returning home after a brief period of observation in the emergency department if the physician determines that it is safe to do so.
Detailed description
An apparent life-threatening event (ALTE) refers to the sudden occurrence in an infant of symptoms such as breathing irregularities, stiffness, or limpness, that appear frightening to caretakers, prompting them to seek medical care. ALTE was first defined in 1986 by an NIH consensus panel. Population-based epidemiologic studies have reported a range of 2.5 to 9.4 ALTE admissions per 1000 live births.
While few ALTEs are truly life-threatening, both clinicians and parents may assume that the infant's life was-and may still be-in danger until proven otherwise. Since the actual risk of an adverse outcome in a well-appearing ALTE patient is unknown, this concern often leads to an extensive diagnostic evaluation and hospitalization to rule out serious occult pathology even when a patient appears well on presentation and has an unremarkable clinical assessment.
Nonspecific inpatient diagnostic evaluations can harm patients by causing complications from invasive testing, false-positive test results, and vulnerable child syndrome. Given these risks and the low probability that such testing will identify a treatable diagnosis in a well-appearing infant, the American Academy of Pediatrics has established a Guideline Committee on ALTEs to develop recommendations for the management of these patients. Specifically, the Committee is formulating criteria to define a low-risk group of infants presenting with ALTE who may be safely discharged after minimal diagnostic testing and a few hours of observation. While an evidence-based clinical guideline has the potential to reduce unnecessary testing and hospital admissions, anecdotal evidence suggests that some parents may have been so frightened by the event that they will resist returning home with their baby even if the objective risk is extremely small. To gather data about parental attitudes, the investigators propose to survey subjects (parents of infants who have experienced an ALTE) to learn whether or not they would accept returning home after a brief period of observation in the emergency department if the physician determines that it is safe to do so. This survey will focus on subject's willingness to forgo admission to the hospital when the risks associated with hospitalization (e.g., hospital-acquired infection, complications of invasive diagnostic procedures) might outweigh the risk of a recurrent ALTE or serious underlying condition. Subject's with an obvious need for admission based on the initial clinical assessment will be excluded, since discharge home would not be an option. Study findings will inform efforts to develop clinical guidelines for the management of an ALTE that take into account both parental attitudes and objective evidence. Without both types of data, implementation of such a guideline will be problematic.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult parents of infants with an apparent life threatening event
Key inclusion criteria (1 listed)
- Adult parents of an infant with an ALTE event
Key exclusion criteria (1 listed)
- Unwilling to sign informed consent document
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 |
|---|---|---|
| InterviewInterview | Other | – |
Primary outcome
Parental comfort level with disposition home from emergency department
Time frame: Subject will be asked to describe their experiences in the ER when their infant was undergoing an evaluation following an apparent life-threatening event. Subject will be interviewed face-to-face or by telephone within 3 years of the event.
Subject response (yes or no) to the following question: Would you have felt comfortable returning home from the emergency department with your baby (rather than admitting baby to the hospital overnight) if the medical evaluation in the emergency department had determined that it would be safe to do so? This question will be asked within the context of a series of questions addressing the subject's experience following the apparent life-threatening event of their infant.
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 6 Feb 2019.
Related trials for ALTE
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALTE, run by NYU Langone Health at 1 site 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 1 inclusion and 1 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Parental comfort level with disposition home from emergency department (time frame: Subject will be asked to describe their experiences in the ER when their infant was undergoing an evaluation following an apparent life-threatening event. Subject will be interviewed face-to-face or by telephone within 3 years of the event.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2019; AzTrials last refreshed its copy on 26 Oct 2026.