Bronchopulmonary DysplasiaNCT03682575
Work of Breathing in Premature Infants at Discharge
An observational study of Bronchopulmonary Dysplasia and Very Low Birth Weight Infant, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU. Read more about this study
- Who is it for?
- Ages 1 month to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia, Very Low Birth Weight Infant, Prematurity
- What is being tested?
- Enrollment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2020to 28 Feb 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 month to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm infants born greater than 26 weeks gestation, weighing less than 1500 grams at birth. Work of breathing indices will be compared between the group of babies who were diagnosed with BPD and the group that was not diagnosed with BPD.
Who may be able to join
- Infants born at greater than 26 weeks gestation, weighing less than 1500 grams at birth.
- Infants with diagnosis of BPD and without diagnosis of BPD
Who cannot join
- Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will 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: Work of Breathing and Oxygen Saturation Stability in Premature Infants With History of Respiratory Insufficiency Prior to Discharge
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU.
Read the detailed description
Work of breathing tests will be performed on premature infants who required oxygen for at least 28 days during their time in NICU. These same work of breathing tests will be performed in another group of premature infants who did not require oxygen for at least 28 days during their time in the NICU. The two groups will be compared.
- Being tested
- Enrollment
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnrollmentOther
All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.
| Study group | Role | What they receive |
|---|---|---|
| Infants WITH diagnosis of bronchopulmonary dysplasia (BPD) | Preterm infants who were on oxygen at 28 days of life. Receives: Other: Enrollment | |
| Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD | Preterm infants who were not on oxygen at 28 days of life. Receives: Other: Enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work of breathing indices
Respiratory Inductance Plethysmography (RIP) measurements will be taken and Phase Angle will be measured.
Measured: 25 minutes
Secondary outcomes (1)
Intermittent Hypoxia
Oxygen saturation will be measured using a 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 posted24 Sep 2018
- Study start10 Nov 2020
- Primary completion17 Nov 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- 78 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, ChristianaCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682575
- Sponsor's protocol ID
- DDD604122
- Status last verified
- Apr 2023
- First submitted
- 21 Sep 2018
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Work of Breathing and Oxygen Saturation Stability in Premature Infants With History of Respiratory Insufficiency Prior to Discharge
- ClinicalTrials.gov ID
- NCT03682575
- Acronym / sponsor ID
- DDD604122
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Sep 2018 (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.
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU.
Detailed description
Work of breathing tests will be performed on premature infants who required oxygen for at least 28 days during their time in NICU. These same work of breathing tests will be performed in another group of premature infants who did not require oxygen for at least 28 days during their time in the NICU. The two groups will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants WITH diagnosis of bronchopulmonary dysplasia (BPD) | – | Other: EnrollmentPreterm infants who were on oxygen at 28 days of life. |
| Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD | – | Other: EnrollmentPreterm infants who were not on oxygen at 28 days of life. |
Who may qualify
- Ages
- 1 month to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infants born greater than 26 weeks gestation, weighing less than 1500 grams at birth. Work of breathing indices will be compared between the group of babies who were diagnosed with BPD and the group that was not diagnosed with BPD.
Key inclusion criteria (2 listed)
- Infants born at greater than 26 weeks gestation, weighing less than 1500 grams at birth.
- Infants with diagnosis of BPD and without diagnosis of BPD
Key exclusion criteria (1 listed)
- Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will 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 |
|---|---|---|
| EnrollmentAll infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing. | Other | Infants WITH diagnosis of bronchopulmonary dysplasia (BPD), Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD |
Primary outcome
Work of breathing indices
Time frame: 25 minutes
Respiratory Inductance Plethysmography (RIP) measurements will be taken and Phase Angle will be measured.
1 secondary outcome
Intermittent Hypoxia
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 18 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Bronchopulmonary Dysplasia
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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
ChristianaCare
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 Bronchopulmonary Dysplasia and Very Low Birth Weight 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 2 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 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 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 18 Apr 2023.