Infant, Newborn, DiseaseCOCONCT04792099
CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial
A study testing Continuous positive airway pressure and Nasal Cannula in people with Infant, Newborn, Disease and Hypoxia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine if in preterm infants < 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Newborn, Disease, Hypoxia, Respiratory Distress Syndrome
- What is being tested?
- Continuous positive airway pressure and Nasal Cannula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 29 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants must be currently utilizing CPAP (without a rate) with a PEEP ≤ 5 and FiO2 ≤ 30%
- Infants must meet CPAP stability criteria as follow:
- If previously intubated, must be extubated ≥ 72 hours
- < 3 self-resolving apneas (≤ 20 s) and/or bradycardia (< 100 bpm) in any hour over previous 6 hours)
- Gestational age < 34 weeks' gestation at birth
- Informed consent by parents/legal guardians
Who cannot join
- presence of a major malformation
- a neuromuscular condition that affects respiration
- a terminal illness or decision to withhold or limit support
- currently being treated for sepsis
- enrollment in a competing trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if in preterm infants < 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 24-hour randomized controlled trial. This will be a randomized controlled trial with a 1:1 parallel allocation of infants to CPAP or NC oxygen using stratified permuted block design.
Read the detailed description
We hope to determine whether in preterm infants < 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 24-hour randomized controlled trial.
This study will include preterm infants < 34 weeks' gestation on respiratory support via CPAP with a PEEP ≤ 5 and FiO2 ≤ 30%. There will be two randomization strata [≥ 22+0/7 to ≤ 27+0/7 weeks, and ≥ 27+1/7 to ≤ 33+6/7 weeks. The purpose of stratification is to ensure an appropriate distribution of risk between study arms. This study will not be powered to detect outcome differences within or between strata.
Following informed consent, randomization, stratified by gestational age at delivery, will be performed using sequentially numbered sealed opaque envelopes. Each envelope will indicate either Treatment group (CPAP group) or Control group (NC group). The envelope will only be opened after informed consent has been obtained and just before starting the study on each infant.
This will be a single center randomized controlled trial with a 1:1 parallel allocation of infants to CPAP or NC oxygen using stratified permuted block design. 15-30 minutes will be provided as a washout period at the beginning of the intervention, followed by 24 hours on the intervention. Infants enrolled must meet CPAP stability criteria that are based on prior randomized clinical trials of weaning from CPAP to NC.
All infants enrolled in the study will have routine monitoring, uniform target saturation ranges of 91-95% with alarm limits set at 88-95%, and standard care for the duration of the study. The high alarm limit will be increased to 100% if an infant is weaned to 21% FiO2. Supplemental FiO2 will be titrated per unit routine to achieve goal target saturations. Pulse oximetry recordings will be downloaded using ixTrend (iexcellence, Wildau, Germany) software to a secure computer system or via Bedmaster software for later data analysis. The target oxygen saturations (91 to 95%) are based on data from the meta-analysis of randomized controlled trials of oxygen saturation targets which included data on 4911 infants from the SUPPORT, COT, and BOOST II trials.
Primary and secondary outcomes are described below. Other safety outcomes include recordings of episodes of bradycardia and circumstances surrounding the event. Pulse oximetry recordings will be downloaded using ixTrend software to a secure computer system for later data analysis. Abdominal and cerebral NIRS will also be performed with subsequent data analysis..
- Conditions
- Infant, Newborn, Disease, Hypoxia, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- Being tested
- Continuous positive airway pressure, Nasal Cannula
- Medical subject headings
- Disease, Hypoxia, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureProcedure or surgery
Also called CPAP
After study entry, CPAP will be provided via mask or binasal prongs in order to have a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery. A PEEP of 5 will be used for uniformity.
Nasal CannulaProcedure or surgery
Also called NC
After study entry, flow will be set to 0.5 L/kg with 1L maximum while on NC during the study period to reduce the risk of inadvertent PEEP with higher flows. Initial FiO2 can be titrated to achieve target saturations, and may be increased up to 100% while on NC.
| Study group | Role | What they receive |
|---|---|---|
| Continuous positive airway pressure | Experimental | Continuous positive airway pressure (CPAP) with blended oxygen delivered by binasal prongs or nasal mask. Receives: Procedure: Continuous positive airway pressure |
| Nasal Cannula | Active comparator | Blended oxygen delivered by nasal cannula (NC). Receives: Procedure: Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of episodes with oxygen saturations less than 85% for ≥ 10 seconds
Measured: 24 hours of intervention
Secondary outcomes (10)
The coefficient of variability of oxygen saturations (relative standard deviation)
The coefficient of variation is a standardized measure of dispersion of a frequency distribution defined as the ratio of the standard deviation to the mean. It will be used in this study to assess the stability of oxygen saturations.
Measured: 24 hours of intervention
The proportion of time with oxygen saturations > 95 % among infants requiring supplemental oxygen
Measured: 24 hours of intervention
The proportion of time spent outside oxygen saturation target ranges (91-95%) among infants requiring supplemental oxygen
Measured: 24 hours of intervention
The proportion of time with oxygen saturations less than 85%
Measured: 24 hours of intervention
The median supplemental oxygen concentration
Measured: 24 hours of intervention
The median transcutaneous carbon dioxide value
Measured: 24 hours of intervention
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80 %
Measured: 24 hours of intervention
The number of recorded episodes (≥ 10 seconds) of bradycardia < 100/min
Measured: 24 hours of intervention
The median cNIRS value
Median cerebral near-infrared spectroscopy value during the 24 hour intervention period
Measured: 24 hours of intervention
The median aNIRS value
Median abdominal near-infrared spectroscopy value during the 24 hour intervention period
Measured: 24 hours of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start16 Aug 2021
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
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 Infant, Newborn, DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 parallel allocation of infants to CPAP or NC oxygen using randomization with stratified permuted block design
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siamak Yazdi, University of Alabama at Birmingham
- Investigators
- Waldemar A Carlo, MD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792099
- Sponsor's protocol ID
- UAB Neo ZY 2021
- Acronym
- COCO
- Status last verified
- Jan 2024
- First submitted
- 5 Mar 2021
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yazdi S, Carlo WA, Nakhmani A, Boateng EO, Aban I, Ambalavanan N, Travers CP. Extended CPAP or low-flow nasal cannula for intermittent hypoxaemia in preterm infants: a 24-hour randomised clinical trial. Arch Dis Child Fetal Neonatal Ed. 2024 Aug 16;109(5):557-561. doi: 10.1136/archdischild-2023-326605.
PubMed 38365446
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04792099
- Acronym / sponsor ID
- COCO / UAB Neo ZY 2021
- Conditions
- Infant, Newborn, Disease, Hypoxia, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 10 Mar 2021 (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 determine if in preterm infants < 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 24-hour randomized controlled trial. This will be a randomized controlled trial with a 1:1 parallel allocation of infants to CPAP or NC oxygen using stratified permuted block design.
Detailed description
We hope to determine whether in preterm infants < 34 weeks' gestation at birth receiving respiratory support with continuous positive airway pressure (CPAP) or nasal cannula (NC), CPAP compared with NC will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 24-hour randomized controlled trial.
This study will include preterm infants < 34 weeks' gestation on respiratory support via CPAP with a PEEP ≤ 5 and FiO2 ≤ 30%. There will be two randomization strata [≥ 22+0/7 to ≤ 27+0/7 weeks, and ≥ 27+1/7 to ≤ 33+6/7 weeks. The purpose of stratification is to ensure an appropriate distribution of risk between study arms. This study will not be powered to detect outcome differences within or between strata.
Following informed consent, randomization, stratified by gestational age at delivery, will be performed using sequentially numbered sealed opaque envelopes. Each envelope will indicate either Treatment group (CPAP group) or Control group (NC group). The envelope will only be opened after informed consent has been obtained and just before starting the study on each infant.
This will be a single center randomized controlled trial with a 1:1 parallel allocation of infants to CPAP or NC oxygen using stratified permuted block design. 15-30 minutes will be provided as a washout period at the beginning of the intervention, followed by 24 hours on the intervention. Infants enrolled must meet CPAP stability criteria that are based on prior randomized clinical trials of weaning from CPAP to NC.
All infants enrolled in the study will have routine monitoring, uniform target saturation ranges of 91-95% with alarm limits set at 88-95%, and standard care for the duration of the study. The high alarm limit will be increased to 100% if an infant is weaned to 21% FiO2. Supplemental FiO2 will be titrated per unit routine to achieve goal target saturations. Pulse oximetry recordings will be downloaded using ixTrend (iexcellence, Wildau, Germany) software to a secure computer system or via Bedmaster software for later data analysis. The target oxygen saturations (91 to 95%) are based on data from the meta-analysis of randomized controlled trials of oxygen saturation targets which included data on 4911 infants from the SUPPORT, COT, and BOOST II trials.
Primary and secondary outcomes are described below. Other safety outcomes include recordings of episodes of bradycardia and circumstances surrounding the event. Pulse oximetry recordings will be downloaded using ixTrend software to a secure computer system for later data analysis. Abdominal and cerebral NIRS will also be performed with subsequent data analysis..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 parallel allocation of infants to CPAP or NC oxygen using randomization with stratified permuted block design
| Arm | Type | Receives |
|---|---|---|
| Continuous positive airway pressure | Experimental | Procedure: Continuous positive airway pressureContinuous positive airway pressure (CPAP) with blended oxygen delivered by binasal prongs or nasal mask. |
| Nasal Cannula | Active comparator | Procedure: Nasal CannulaBlended oxygen delivered by nasal cannula (NC). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Infants must be currently utilizing CPAP (without a rate) with a PEEP ≤ 5 and FiO2 ≤ 30%
- Infants must meet CPAP stability criteria as follow:
- If previously intubated, must be extubated ≥ 72 hours
- < 3 self-resolving apneas (≤ 20 s) and/or bradycardia (< 100 bpm) in any hour over previous 6 hours)
- Gestational age < 34 weeks' gestation at birth
Key exclusion criteria (5 listed)
- presence of a major malformation
- a neuromuscular condition that affects respiration
- a terminal illness or decision to withhold or limit support
- currently being treated for sepsis
- enrollment in a competing trial
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 |
|---|---|---|
| Continuous positive airway pressureAlso: CPAPAfter study entry, CPAP will be provided via mask or binasal prongs in order to have a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery. A PEEP of 5 will be used for uniformity. | Procedure or surgery | Continuous positive airway pressure |
| Nasal CannulaAlso: NCAfter study entry, flow will be set to 0.5 L/kg with 1L maximum while on NC during the study period to reduce the risk of inadvertent PEEP with higher flows. Initial FiO2 can be titrated to achieve target saturations, and may be increased up to 100% while on NC. | Procedure or surgery | Nasal Cannula |
Primary outcome
The number of episodes with oxygen saturations less than 85% for ≥ 10 seconds
Time frame: 24 hours of intervention
10 secondary outcomes
The coefficient of variability of oxygen saturations (relative standard deviation)
Time frame: 24 hours of intervention
The proportion of time with oxygen saturations > 95 % among infants requiring supplemental oxygen
Time frame: 24 hours of intervention
The proportion of time spent outside oxygen saturation target ranges (91-95%) among infants requiring supplemental oxygen
Time frame: 24 hours of intervention
The proportion of time with oxygen saturations less than 85%
Time frame: 24 hours of intervention
The median supplemental oxygen concentration
Time frame: 24 hours of intervention
The median transcutaneous carbon dioxide value
Time frame: 24 hours of intervention
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80 %
Time frame: 24 hours of intervention
The number of recorded episodes (≥ 10 seconds) of bradycardia < 100/min
Time frame: 24 hours of intervention
The median cNIRS value
Time frame: 24 hours of intervention
The median aNIRS value
Time frame: 24 hours of intervention
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 26 Jan 2024.
- Derived from this study: PubMed 38365446Yazdi S, Carlo WA, Nakhmani A, Boateng EO, Aban I, Ambalavanan N, Travers CP. Extended CPAP or low-flow nasal cannula for intermittent hypoxaemia in preterm infants: a 24-hour randomised clinical trial. Arch Dis Child Fetal Neonatal Ed. 2024 Aug 16;109(5):557-561. doi: 10.1136/archdischild-2023-326605.
- Individual participant dataSharing planned: No
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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.
Waldemar A Carlo, MD study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure and Nasal Cannula in people with Infant, Newborn, Disease and Hypoxia, run by University of Alabama at Birmingham 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 6 inclusion and 5 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 26 Jan 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?
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?
The number of episodes with oxygen saturations less than 85% for ≥ 10 seconds (time frame: 24 hours of intervention). 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 NCT04792099, 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 26 Jan 2024.