Premature InfantNCT03277768
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
An observational study of Premature Infant and Patent Ductus Arteriosus, run by University of Florida at 2 sites in United States.
Trial summary
The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at < 30 weeks of gestation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Infant, Patent Ductus Arteriosus, Hemodynamic Instability
- What is being tested?
- Resonance Raman Spectroscopy (RRS)
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2015to 23 Aug 2018
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Premature infants born <30 weeks gestational age and admitted to the Boston Children's Hospital neonatal intensive care unit (NICU), Brigham and Women's NICU, and the University of Florida NICU.
Who may be able to join
- Infants < 30 weeks estimated gestational age
Who cannot join
- Infants with major congenital anomalies
- Infants >34 weeks post-menstrual age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
University of Florida
Gainesville, Florida, 32610
About this study
The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at < 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.
- Being tested
- Resonance Raman Spectroscopy (RRS)
- Keywords
- Premature infant, Tissue Oxygenation, Patent Ductus Arteriosus
- Medical subject headings
- Premature Birth, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance Raman Spectroscopy (RRS)Device
Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.
| Study group | Role | What they receive |
|---|---|---|
| Control Group -Patent Ductus Arteriosus Absent | Not described Receives: Device: Resonance Raman Spectroscopy (RRS) | |
| Study Group - Patent Ductus Arteriosus Present | Not described Receives: Device: Resonance Raman Spectroscopy (RRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.
Measured: Up to a maximum of 14 data collection times
Secondary outcomes (1)
Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.
RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event.
Measured: Up to a maximum of 14 data collection times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 May 2015
- Primary completionSep 2017
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- J Lauren Ruoss, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277768
- Sponsor's protocol ID
- IRB201601508
- Status last verified
- Sep 2019
- First submitted
- 1 Sep 2017
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The analysis of the data will be shared with other research. Individual patient data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
- ClinicalTrials.gov ID
- NCT03277768
- Acronym / sponsor ID
- IRB201601508
- Keywords
- Premature infant, Tissue Oxygenation, Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- 1 May 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 11 Sep 2017 (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 proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at < 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group -Patent Ductus Arteriosus Absent | – | Device: Resonance Raman Spectroscopy (RRS) |
| Study Group - Patent Ductus Arteriosus Present | – | Device: Resonance Raman Spectroscopy (RRS) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Premature infants born <30 weeks gestational age and admitted to the Boston Children's Hospital neonatal intensive care unit (NICU), Brigham and Women's NICU, and the University of Florida NICU.
Key inclusion criteria (1 listed)
- Infants < 30 weeks estimated gestational age
Key exclusion criteria (2 listed)
- Infants with major congenital anomalies
- Infants >34 weeks post-menstrual age
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 |
|---|---|---|
| Resonance Raman Spectroscopy (RRS)Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs. | Device | Control Group -Patent Ductus Arteriosus Absent, Study Group - Patent Ductus Arteriosus Present |
Primary outcome
Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
Time frame: Up to a maximum of 14 data collection times
Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.
1 secondary outcome
Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.
Time frame: Up to a maximum of 14 data collection times
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 10 Sep 2019.
- Individual participant dataSharing planned: No. The analysis of the data will be shared with other research. Individual patient data will not be shared.
Related trials for Premature Infant
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
J Lauren Ruoss, MD principal investigator
University of Florida
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 Premature Infant and Patent Ductus Arteriosus, run by University of Florida 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 1 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 10 Sep 2019. 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?
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?
Differences and pre- and post-ductal RRS measurements of tissue oxygenation. (time frame: Up to a maximum of 14 data collection times). 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 10 Sep 2019.