Newborn ComplicationNCT04154618
Continuous Vital Sign Monitoring in Newborns
An observational study of Newborn Complication, run by Northwell Health at 2 sites in United States.
Trial summary
This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization. Read more about this study
- Who is it for?
- Ages 0 to 12 hours
- Conditions the study is for
- Newborn Complication
- What is being tested?
- Continuous wireless vital sign monitoring
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2020to 31 Dec 2025
- 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 0 to 12 hours
- All sexes
- No healthy volunteers
- Child
Study population: Healthy newborn infants < 12 hours of age admitted to the Well Baby Nursery
Who may be able to join
- Healthy infants <12 hours of age
- Expected to be admitted to the Well Baby Nursery
- 36 or more weeks gestation at birth
- Mother at least 18 years of age
Who cannot join
- Infants requiring any non-routine medical care or observation
- Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission
- Multiple birth
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Debra C Potak, RN, 516-838-6436, dpotak@northwell.edu
Barry Weinberger, MD, 718 470-3440, bweinberger@northwell.edu
- Not yet recruiting
Phelps Hospital
Sleepy Hollow, New York, 10591
Mazen T Khalifeh, MD, 914-269-1914, mkhalifeh@northwell.edu
Mazen T Khalifeh, MD
About this study
This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.
Read the detailed description
This study is conducted for the purposes of understanding the feasibility and acceptability of routine wireless continuous monitoring on healthy newborns as a standard practice \& its effect on existing workflows and as a future tool for the early detection of undiagnosed problems. All infants will receive routine newborn nursing care .
Once alarm limits have been determined, the monitoring data will be analyzed in real time and out of range vital signs will alert the nurse to perform standard assessment of the newborn.
Nurse and parents will complete surveys regarding their experience with continuous vital sign monitoring.
- Conditions
- Newborn Complication
- Being tested
- Continuous wireless vital sign monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous wireless vital sign monitoringDevice
Infants will receive wireless vital sign monitoring throughout their birth hospitalization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).
TAM questionnaires will be distributed to the nurse taking care of each subject at the time of discharge of the infant. The questionnaire will include informed consent by the nurse for participation in the research. A similar questionnaire will also be distributed to the mother just prior to discharge.
Measured: Up to 3 days
Secondary outcomes (2)
Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window
The mean continuous measurements within a 2-minute window around each conventional vital sign assessment (routinely, several in the first 4 hours after birth, and then every 12 hours) will be compared to the routine measurement.
Measured: Up to 3 days
Clinical Utility as measured by false alerts
Quantify false positive alerts and false negative alerts as a measure of potential adverse effect on nursing workflow and patient care
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start18 Feb 2020
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn ComplicationStudies of the same condition, open and under way.
- More trials run by Northwell 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health
- Responsible party
- Principal investigator, Barry Weinberger, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154618
- Sponsor's protocol ID
- 19-0653
- Status last verified
- Apr 2023
- First submitted
- 11 Oct 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Vital Sign Monitoring in Newborns
- ClinicalTrials.gov ID
- NCT04154618
- Acronym / sponsor ID
- 19-0653
- Conditions
- Newborn Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- New York State Department of Health
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Nov 2019 (actual)
- 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.
This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.
Detailed description
This study is conducted for the purposes of understanding the feasibility and acceptability of routine wireless continuous monitoring on healthy newborns as a standard practice \& its effect on existing workflows and as a future tool for the early detection of undiagnosed problems. All infants will receive routine newborn nursing care .
Once alarm limits have been determined, the monitoring data will be analyzed in real time and out of range vital signs will alert the nurse to perform standard assessment of the newborn.
Nurse and parents will complete surveys regarding their experience with continuous vital sign monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy newborn infants < 12 hours of age admitted to the Well Baby Nursery
Key inclusion criteria (4 listed)
- Healthy infants <12 hours of age
- Expected to be admitted to the Well Baby Nursery
- 36 or more weeks gestation at birth
- Mother at least 18 years of age
Key exclusion criteria (3 listed)
- Infants requiring any non-routine medical care or observation
- Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission
- Multiple birth
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 |
|---|---|---|
| Continuous wireless vital sign monitoringInfants will receive wireless vital sign monitoring throughout their birth hospitalization. | Device | – |
Primary outcome
Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).
Time frame: Up to 3 days
TAM questionnaires will be distributed to the nurse taking care of each subject at the time of discharge of the infant. The questionnaire will include informed consent by the nurse for participation in the research. A similar questionnaire will also be distributed to the mother just prior to discharge.
2 secondary outcomes
Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window
Time frame: Up to 3 days
Clinical Utility as measured by false alerts
Time frame: Up to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD).
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A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
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Growing Little PEAPODS Study
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Complication, run by Northwell Health at 2 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barry Weinberger, MD (718-470-3440, BWeinberger@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM). (time frame: Up to 3 days). 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 18 Apr 2023.