Respiratory Distress Syndrome, NewbornNCT05961670
Application of Lung Near-Infrared Spectroscopy (NIRS) in Preterm Infants
An observational study of Respiratory Distress Syndrome, Newborn, run by Keck School of Medicine of USC at 1 site in United States.
Trial summary
Premature infants are more likely to develop hypoxemia after birth often requiring invasive and Non-Invasive Mechanical ventilation and surfactant therapy to improve alveolar gas exchange and oxygen transport. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Neer Infrared Spectroscopy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 30 Sep 2024
- 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 hour to 24 hours
- All sexes
- Child
Study population: Inborn premature infants
Who may be able to join
- Infants born between 23-32 weeks of gestation admitted to the Neonatal Intensive Care Unit with respiratory distress receiving non-invasive ventilation and requiring Surfactant Replacement Therapy.
Who cannot join
- Neonates with no need for respiratory support/Surfactant. Neonates with congenital malformations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles General Medical Center
Los Angeles, California, 90033
Manoj Biniwale
About this study
Official title: Application of Lung Near-Infrared Spectroscopy (NIRS) During Invasive and Non-Invasive Ventilation and Pre- and Post-Surfactant Administration in Preterm Infants
Premature infants are more likely to develop hypoxemia after birth often requiring invasive and Non-Invasive Mechanical ventilation and surfactant therapy to improve alveolar gas exchange and oxygen transport. Near-infrared spectroscopy (NIRS) has been used to detect pulmonary regional oxygen saturation (rpSO 2 ) as well as cerebral regional oxygen saturation (rcSO2 ) and evaluate the oxygenation state of the lung and brain. This is a prospective observational study to evaluate utility of rpSO2 and compare it with rcSO2 in preterm infants born between 23-32 weeks of gestation receiving noninvasive ventilation and surfactant treatment. Enrolled patients will be continuously studied with placement of NIRS monitor using cerebral sensor (INVOS™) for 6 hrs and 15 min before and after surfactant administration. Pulmonary regional oxygen saturation (rpSO2) with a sampling interval of 6 s will be followed for 6hrs.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Neer Infrared Spectroscopy
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neer Infrared SpectroscopyDevice
Premature infants will be studied with brain and lung NIRS before and after surfactant administration
What is being measured
The primary outcome is the main question the study is designed to answer.
rpSO2 before and after surfactant therapy
brain and lung rpSO2 will be compared before and after surfactant administration
Measured: 6 hours
Secondary outcomes (2)
variations on rpSO2 and rcSO2 during changes in ventilation modes
Will evaluate for variations with various ventilation modes
Measured: 6 hours
correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I
Correlation will be assessed between rpSO2 and other ratios
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keck School of Medicine of USC
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Manoj Biniwale, Keck School of Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961670
- Sponsor's protocol ID
- 13184
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Lung Near-Infrared Spectroscopy (NIRS) During Invasive and Non-Invasive Ventilation and Pre- and Post-Surfactant Administration in Preterm Infants
- ClinicalTrials.gov ID
- NCT05961670
- Acronym / sponsor ID
- 13184
- Conditions
- Respiratory Distress Syndrome, Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Keck School of Medicine of USCUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 27 Jul 2023 (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.
Premature infants are more likely to develop hypoxemia after birth often requiring invasive and Non-Invasive Mechanical ventilation and surfactant therapy to improve alveolar gas exchange and oxygen transport. Near-infrared spectroscopy (NIRS) has been used to detect pulmonary regional oxygen saturation (rpSO 2 ) as well as cerebral regional oxygen saturation (rcSO2 ) and evaluate the oxygenation state of the lung and brain. This is a prospective observational study to evaluate utility of rpSO2 and compare it with rcSO2 in preterm infants born between 23-32 weeks of gestation receiving noninvasive ventilation and surfactant treatment. Enrolled patients will be continuously studied with placement of NIRS monitor using cerebral sensor (INVOS™) for 6 hrs and 15 min before and after surfactant administration. Pulmonary regional oxygen saturation (rpSO2) with a sampling interval of 6 s will be followed for 6hrs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Age groups
- Child
- Study population
- Inborn premature infants
Key inclusion criteria (1 listed)
- Infants born between 23-32 weeks of gestation admitted to the Neonatal Intensive Care Unit with respiratory distress receiving non-invasive ventilation and requiring Surfactant Replacement Therapy.
Key exclusion criteria (1 listed)
- Neonates with no need for respiratory support/Surfactant. Neonates with congenital malformations.
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 |
|---|---|---|
| Neer Infrared SpectroscopyPremature infants will be studied with brain and lung NIRS before and after surfactant administration | Device | – |
Primary outcome
rpSO2 before and after surfactant therapy
Time frame: 6 hours
brain and lung rpSO2 will be compared before and after surfactant administration
2 secondary outcomes
variations on rpSO2 and rcSO2 during changes in ventilation modes
Time frame: 6 hours
correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Respiratory Distress Syndrome, Newborn, run by Keck School of Medicine of USC 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manoj Biniwale, MD (3234093406, Biniwale@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rpSO2 before and after surfactant therapy (time frame: 6 hours). 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 27 Jul 2023.