Apnea of PrematurityNCT03695900
Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants
A study testing Targeting SpO2 at 93-95% and Targeting SpO2 at 90-92% in people with Apnea of Prematurity and Desaturation of Blood, run by University of Miami at 1 site in United States.
Trial summary
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. Read more about this study
- Who is it for?
- Ages Up to 18 weeks
- Conditions the study is for
- Apnea of Prematurity, Desaturation of Blood, Central Apnea
- What is being tested?
- Targeting SpO2 at 93-95% and Targeting SpO2 at 90-92%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 8 Nov 2019
- Phase
- Interventional
- 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 Up to 18 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 23 0/7- 29 6/7 weeks gestational age
- Postnatal age ≥ 14 days
- Requiring FiO2 ≥ 0.25 to keep SpO2 90-95%
- Parental informed consent
Who cannot join
- Severe congenital anomalies that may affect pulmonary or neurosensory development
- Severe CNS pathology that may alter respiratory control function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Arterial Oxygen Saturation Range on Ventilatory Stability in Extremely Premature Infants
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).
- Conditions
- Apnea of Prematurity, Desaturation of Blood, Central Apnea, Periodic Breathing, Obstructive Apnea of Newborn
- Being tested
- Targeting SpO2 at 93-95%, Targeting SpO2 at 90-92%
- Medical subject headings
- Apnea, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeting SpO2 at 93-95%Other
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours
Targeting SpO2 at 90-92%Other
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Targeting SpO2 at 93-95% followed by targeting at 90-92% | Other | FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours. Receives: Other: Targeting SpO2 at 93-95%; Other: Targeting SpO2 at 90-92% |
| Targeting SpO2 at 90-92% followed by targeting at 93-95% | Other | FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours. Receives: Other: Targeting SpO2 at 93-95%; Other: Targeting SpO2 at 90-92% |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilatory stability by frequency of central apnea
by frequency of central apnea
Measured: 2 hours
ventilatory stability by frequency of obstructive apnea
by frequency of obstructive apnea
Measured: 2 hours
ventilatory stability by density of periodic breathing
by density of periodic breathing
Measured: 2 hours
ventilatory stability by time series of inter-breath intervals
by time series of inter-breath intervals
Measured: 2 hours
Secondary outcomes (2)
oxygenation stability by frequency of intermittent hypoxemia episodes
frequency of episodes with SpO2 < 80%
Measured: 2 hours
frequency of bradycardia episodes
frequency of episodes with HR < 100 bpm
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Nov 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2, 93-95% vs 90-92%) on ventilatory stability in premature infants.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Nelson Claure, University of Miami
- Investigators
- Nelson Claure, MSc, PhD, Principal investigator, University of MiamiEduardo Bancalari, MD, Principal investigator, University of MiamiDeepak Jain, MD, Principal investigator, University of MiamiWaleed Kurtom, MD, Principal investigator, Jackson Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695900
- Sponsor's protocol ID
- 20180536
- Status last verified
- May 2023
- First submitted
- 2 Oct 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurtom W, Dormishian A, Jain D, Schott A, Aguilar AC, Grieb G, Bancalari E, Claure N. Effect of the Target Range on Arterial Oxygen Saturation Stability in Extremely Premature Infants. Neonatology. 2022;119(5):638-643. doi: 10.1159/000525271. Epub 2022 Aug 26.
PubMed 36030769
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Arterial Oxygen Saturation Range on Ventilatory Stability in Extremely Premature Infants
- ClinicalTrials.gov ID
- NCT03695900
- Acronym / sponsor ID
- 20180536
- Conditions
- Apnea of Prematurity, Desaturation of Blood, Central Apnea, Periodic Breathing, Obstructive Apnea of Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 4 Oct 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.
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2, 93-95% vs 90-92%) on ventilatory stability in premature infants.
| Arm | Type | Receives |
|---|---|---|
| Targeting SpO2 at 93-95% followed by targeting at 90-92% | Other | Other: Targeting SpO2 at 93-95%, Other: Targeting SpO2 at 90-92%FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours. |
| Targeting SpO2 at 90-92% followed by targeting at 93-95% | Other | Other: Targeting SpO2 at 93-95%, Other: Targeting SpO2 at 90-92%FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours. |
Who may qualify
- Ages
- Up to 18 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 23 0/7- 29 6/7 weeks gestational age
- Postnatal age ≥ 14 days
- Requiring FiO2 ≥ 0.25 to keep SpO2 90-95%
- Parental informed consent
Key exclusion criteria (2 listed)
- Severe congenital anomalies that may affect pulmonary or neurosensory development
- Severe CNS pathology that may alter respiratory control function
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 |
|---|---|---|
| Targeting SpO2 at 93-95%FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours | Other | Targeting SpO2 at 90-92% followed by targeting at 93-95%, Targeting SpO2 at 93-95% followed by targeting at 90-92% |
| Targeting SpO2 at 90-92%FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours. | Other | Targeting SpO2 at 90-92% followed by targeting at 93-95%, Targeting SpO2 at 93-95% followed by targeting at 90-92% |
Primary outcome
ventilatory stability by frequency of central apnea
Time frame: 2 hours
by frequency of central apnea
ventilatory stability by frequency of obstructive apnea
Time frame: 2 hours
by frequency of obstructive apnea
ventilatory stability by density of periodic breathing
Time frame: 2 hours
by density of periodic breathing
ventilatory stability by time series of inter-breath intervals
Time frame: 2 hours
by time series of inter-breath intervals
2 secondary outcomes
oxygenation stability by frequency of intermittent hypoxemia episodes
Time frame: 2 hours
frequency of bradycardia episodes
Time frame: 2 hours
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 May 2023.
- Derived from this study: PubMed 36030769Kurtom W, Dormishian A, Jain D, Schott A, Aguilar AC, Grieb G, Bancalari E, Claure N. Effect of the Target Range on Arterial Oxygen Saturation Stability in Extremely Premature Infants. Neonatology. 2022;119(5):638-643. doi: 10.1159/000525271. Epub 2022 Aug 26.
- Individual participant dataSharing planned: No
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Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
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Automated Apnoea Detection in Preterms on Non-invasive Ventilation
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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.
Nelson Claure, MSc, PhD principal investigator
University of Miami
Eduardo Bancalari, MD principal investigator
University of Miami
Deepak Jain, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeting SpO2 at 93-95% and Targeting SpO2 at 90-92% in people with Apnea of Prematurity and Desaturation of Blood, run by University of Miami 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 4 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 May 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?
ventilatory stability by frequency of central apnea (time frame: 2 hours). The study lists 4 primary outcomes in all. 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 NCT03695900, which also lists 1 linked publication.
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 May 2023.