Work of BreathingNCT05209269
Work of Breathing in Term Infants
An observational study of Work of Breathing and Term Infant, run by Christiana Care Health Services at 1 site in United States.
Trial summary
This is a prospective observational cohort study conducted in the mother-baby unit at ChristianaCare. The study is designed to assess work of breathing indices and oxygen saturation stability at discharge in full-term infants. Read more about this study
- Who is it for?
- Ages 1 day to 1 week
- Conditions the study is for
- Work of Breathing, Term Infant
- What is being tested?
- Work of breathing observation
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 31 Aug 2023
- 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 1 day to 1 week
- All sexes
- Child
Study population: Infants born ≥37 weeks gestation admitted to the Mother-Baby Unit
Who may be able to join
- Infants born ≥37 weeks gestation
- Admitted to the Mother-Baby Unit
- Within 24 hours of expected discharge
Who cannot join
- Infants born between < 37week gestation admitted to the Mother-Baby Unit at CCHS
- Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Services, Inc.
Newark, Delaware, 19718
About this study
Official title: Comparing Oxygen Saturation Stability and Work of Breathing Between Normal Term Infants and Premature Infants Prior to Discharge
This is a prospective observational cohort study conducted in the mother-baby unit at ChristianaCare. The study is designed to assess work of breathing indices and oxygen saturation stability at discharge in full-term infants. Data obtained will be used to perform a comparative analysis on work of breathing data for premature infants obtained from our previous study. We hypothesize full term (≥37 weeks gestation) infants have decreased work of breathing indices (i.e., phase angle) compared to premature infants (born 26-37 weeks gestation) at discharge.
- Conditions
- Work of Breathing, Term Infant
- Being tested
- Work of breathing observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work of breathing observationOther
We will place soft elastic bands around the infant's chest and abdomen to assess their work of breathing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Work of breathing indices
A phase angel of 0 represents perfect synchrony between the chest and abdominal compartments. Higher phase angles represent greater degrees of asynchronous breathing. A phase angle of ≥ 40 represents asynchrony and increased work of breathing. A phase angle of 180 represents complete asynchrony.
Measured: 25 minutes
Secondary outcomes (1)
Oxygen saturations
Oxygen saturations will be measured by the high-resolution pulse oximeter.
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start22 Apr 2022
- Primary completion1 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work of BreathingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelley Z Kovatis, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209269
- Sponsor's protocol ID
- DDD605112
- Status last verified
- Sep 2023
- First submitted
- 12 Jan 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be shared with our statistical colleagues. Published data will be in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Oxygen Saturation Stability and Work of Breathing Between Normal Term Infants and Premature Infants Prior to Discharge
- ClinicalTrials.gov ID
- NCT05209269
- Acronym / sponsor ID
- DDD605112
- Conditions
- Work of Breathing, Term Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 26 Jan 2022 (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 is a prospective observational cohort study conducted in the mother-baby unit at ChristianaCare. The study is designed to assess work of breathing indices and oxygen saturation stability at discharge in full-term infants. Data obtained will be used to perform a comparative analysis on work of breathing data for premature infants obtained from our previous study. We hypothesize full term (≥37 weeks gestation) infants have decreased work of breathing indices (i.e., phase angle) compared to premature infants (born 26-37 weeks gestation) at discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 1 week
- Sex
- All
- Age groups
- Child
- Study population
- Infants born ≥37 weeks gestation admitted to the Mother-Baby Unit
Key inclusion criteria (3 listed)
- Infants born ≥37 weeks gestation
- Admitted to the Mother-Baby Unit
- Within 24 hours of expected discharge
Key exclusion criteria (2 listed)
- Infants born between < 37week gestation admitted to the Mother-Baby Unit at CCHS
- Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will also be excluded.
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 |
|---|---|---|
| Work of breathing observationWe will place soft elastic bands around the infant's chest and abdomen to assess their work of breathing. | Other | – |
Primary outcome
Work of breathing indices
Time frame: 25 minutes
A phase angel of 0 represents perfect synchrony between the chest and abdominal compartments. Higher phase angles represent greater degrees of asynchronous breathing. A phase angle of ≥ 40 represents asynchrony and increased work of breathing. A phase angle of 180 represents complete asynchrony.
1 secondary outcome
Oxygen saturations
Time frame: 25 minutes
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 11 Sep 2023.
- Individual participant dataSharing planned: No. De-identified data will be shared with our statistical colleagues. Published data will be in aggregate form.
Related trials for Work of Breathing
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Little Lungs Study
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The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
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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.
Kelley Z Kovatis, MD principal investigator
Christiana Care Health Services
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 Work of Breathing and Term Infant, run by Christiana Care Health Services 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 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 11 Sep 2023. 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?
Work of breathing indices (time frame: 25 minutes). 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 11 Sep 2023.