Prematurity; ExtremeNCT04639583

Use of NIRS in Preterm Population Born at Altitude

A study testing Near-infrared spectroscopy (NIRS) utilization in people with Prematurity; Extreme, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of "normal" values is… Read more about this study

Who is it for?: Ages 0 to 24 hours
Conditions the study is for: Prematurity; Extreme
What is being tested?: Near-infrared spectroscopy (NIRS) utilization
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2021to 30 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 24 hours
All sexes
No healthy volunteers
Child

Who may be able to join

Infant must be <32 weeks' gestational age at time of delivery.
Consenting mother/guardian of the infant must speak English. Other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. Additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients.
Infants that require blood transfusions during the monitoring time may be included.

Who cannot join

Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow.
Infant born after placental abruption or concern for extreme blood loss immediately after birth.
Unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery).
Mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed.
Mothers/guardians that are <18 years of age will not be approached for consent.
Any mother/guardian that is not able to consent due to having a legal representative will not be approached for consent in this study.
Any infant that is planned to be placed for adoption
Infant is greater than 24 hours of age at time of consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of New Mexico
Albuquerque, New Mexico, 87131

Other trials in United States

About this study

Official title: Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude

Conditions: Prematurity; Extreme
Being tested: Near-infrared spectroscopy (NIRS) utilization
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Near-infrared spectroscopy (NIRS) utilizationDevice
The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.

Study groups in NCT04639583
Study group	Role	What they receive
Observational Arm	Experimental	Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Receives: Device: Near-infrared spectroscopy (NIRS) utilization

What is being measured

The primary outcome is the main question the study is designed to answer.

Cerebral Regional Oxygen Saturation (cRSO2)
Measure cRSO2 for the first 96 hours of life in infants born preterm.
Measured: first 96 hours of life

Secondary outcomes (1)

Incidence of Major Complications of Prematurity
Additional items recorded to determine if there is any correlation with the cRSO2 values, including death, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, duration of supplemental oxygen required, time to taking full volume feeds via nippling, and hospital length of stay.
Measured: From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202130 Jun 2023

First posted20 Nov 2020
Study start1 Oct 2021
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prematurity; ExtremeStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: The study will be a prospective observational study, in which any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life.
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04639583
Sponsor's protocol ID: 20-382
Status last verified: May 2024
First submitted: 1 Nov 2020
Last updated: 29 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prematurity; Extreme trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude
ClinicalTrials.gov ID: NCT04639583
Acronym / sponsor ID: 20-382
Conditions: Prematurity; Extreme
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of New MexicoUniversity, hospital or other
Study start: 1 Oct 2021 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 20 Nov 2020 (actual)
Results: Posted 29 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study will be a prospective observational study, in which any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life.

Arm	Type	Receives
Observational Arm	Experimental	Device: Near-infrared spectroscopy (NIRS) utilizationAny infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time.

Who may qualify

Ages: 0 to 24 hours
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Infant must be <32 weeks' gestational age at time of delivery.
Consenting mother/guardian of the infant must speak English. Other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. Additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients.
Infants that require blood transfusions during the monitoring time may be included.

Key exclusion criteria (8 listed)

Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow.
Infant born after placental abruption or concern for extreme blood loss immediately after birth.
Unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery).
Mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed.
Mothers/guardians that are <18 years of age will not be approached for consent.

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
Near-infrared spectroscopy (NIRS) utilizationThe NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.	Device	Observational Arm

Primary outcome

Cerebral Regional Oxygen Saturation (cRSO2)
Time frame: first 96 hours of life
Measure cRSO2 for the first 96 hours of life in infants born preterm.

1 secondary outcome

Incidence of Major Complications of Prematurity
Time frame: From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age.

Results and safety

Results posted to the registry on 29 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational Arm	21	20

Primary outcome: Cerebral Regional Oxygen Saturation (cRSO2)

Time frame: first 96 hours of life. Mean (Full Range). Unit: percent rcSO2

Measure	Observational Arm n = 20
Value	73.4 (15 to 95)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: birth until discharge from birth hospitalization (up to 1 year of age). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Arm	19 of 21 (90.5%)	0 of 21 (0%)	1 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Prematurity; Extreme

Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Near-infrared spectroscopy (NIRS) utilization in people with Prematurity; Extreme, run by University of New Mexico 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 8 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 29 May 2024. 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?

Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cerebral Regional Oxygen Saturation (cRSO2) (time frame: first 96 hours of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04639583.

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 29 May 2024.