Apparent Life Threatening Events in Infants

February 4, 2019 updated by: NYU Langone Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult parents of infants with an apparent life threatening event

Description

Inclusion Criteria:

  • Adult parents of an infant with an ALTE event

Exclusion Criteria:

  • Unwilling to sign informed consent document

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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