Bronchopulmonary DysplasiaNCT05547139
Impact of Extended CPAP on Bronchopulmonary Dysplasia
A study testing Protocolized weaning of respiratory support in people with Bronchopulmonary Dysplasia and Prematurity, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning… Read more about this study
- Who is it for?
- Ages 22 to 30 weeksHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia, Prematurity
- What is being tested?
- Protocolized weaning of respiratory support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 31 Jul 2024
- 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 22 to 30 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- babies born at <30 weeks' gestation
- babies who are extubated to non-invasive ventilation by 32 weeks postmenstrual age
Who cannot join
- babies born at <30 weeks' gestation
- requiring less than 2L NC at birth or
- those who are extubated after 32.0 weeks' postmenstrual age
- congenital anomalies
- skeletal disorders
- neuromuscular disorders
- genetic syndromes
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Services, Inc.
Newark, Delaware, 19718
About this study
Official title: Impact of Extended CPAP Utilization on Bronchopulmonary Dysplasia in Extremely Premature Infants: A Pilot Randomized Control Trial
The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to HFNC (high flow nasal cannula).
Read the detailed description
There are two ways to help premature babies breathe. Both HFNC and CPAP are commonly used in our NICU. CPAP, which helps your baby breathe without a tube in their windpipe (intubation or ventilator), delivers oxygen and air by pressure through either small prongs in the nose or a nose mask, keeping your baby's airways open. HFNC provides heated and humidified oxygen and air by small prongs in the nose that does not use high pressure to the airways. Our goals are to reduce long term complications such as lung disease of prematurity, also called Bronchopulmonary Dysplasia (BPD). BPD causes "lung damage/scarring, need for a ventilator or oxygen, brain/neurological impairment etc. In recent years, HFNC has become a common choice for care. There is no clear agreement in previous research which way may be best to reduce BPD.
- Conditions
- Bronchopulmonary Dysplasia, Prematurity
- Being tested
- Protocolized weaning of respiratory support
- Keywords
- Bronchopulmonary dysplasia, Prematurity, High flow nasal cannula, Continuous positive airway pressure, NICU
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized weaning of respiratory supportOther
The protocolized weaning aims to keep babies on CPAP for a longer period of time and will measure how long it takes babies to wean to 2L nasal cannula support or come off all support (room air, RA).
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | No intervention | Infants randomized to this group will receive the present standard of care for weaning respiratory support. This means the attending provider will decide when each infant is ready to be changed from CPAP to nasal cannula and the nasal cannula will be weaned according to an existing unit protocol. |
| Protocol care group | Active comparator | Infants randomized to this group will remain on CPAP until they are at least 32 weeks corrected gestational age or 1250g. At that point, if they meet a set of criteria, they will be transitioned to either 2L nasal cannula if they require supplemental oxygen or room air. Receives: Other: Protocolized weaning of respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach 2L NC or room air
The primary outcome is time (in days) to reach 2L nasal cannula or room air
Measured: up to 3 months
Secondary outcomes (1)
Compliance to protocol and balancing measures
compliance to intervention, medical team attitude towards intervention, death, pneumothorax after extubation, septal breakdown, necrotizing enterocolitis (NEC), number of failed wean off respiratory support attempts, duration of noninvasive respiratory support, failure to maintain non-invasive support, duration of Fi02 requirement >21%, need for systemic steroids, time to full enteral feeds, time to initiation of PO feeds, time to >75% PO feeds, length of stay, and growth velocity at discharge.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start10 Oct 2022
- Primary completion31 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants will be randomized to the usual care group or the protocol care group.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelley Z Kovatis, MD, Principal investigator, Christiana Care Health Services, IncAnastasiya Latushko, Principal investigator, Christiana Care Health Services, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547139
- Sponsor's protocol ID
- 605186
- Status last verified
- Aug 2024
- First submitted
- 12 Sep 2022
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Extended CPAP Utilization on Bronchopulmonary Dysplasia in Extremely Premature Infants: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05547139
- Acronym / sponsor ID
- 605186
- Conditions
- Bronchopulmonary Dysplasia, Prematurity
- Keywords
- Bronchopulmonary dysplasia, Prematurity, High flow nasal cannula, Continuous positive airway pressure, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Sep 2022 (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 pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to HFNC (high flow nasal cannula).
Detailed description
There are two ways to help premature babies breathe. Both HFNC and CPAP are commonly used in our NICU. CPAP, which helps your baby breathe without a tube in their windpipe (intubation or ventilator), delivers oxygen and air by pressure through either small prongs in the nose or a nose mask, keeping your baby's airways open. HFNC provides heated and humidified oxygen and air by small prongs in the nose that does not use high pressure to the airways. Our goals are to reduce long term complications such as lung disease of prematurity, also called Bronchopulmonary Dysplasia (BPD). BPD causes "lung damage/scarring, need for a ventilator or oxygen, brain/neurological impairment etc. In recent years, HFNC has become a common choice for care. There is no clear agreement in previous research which way may be best to reduce BPD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants will be randomized to the usual care group or the protocol care group.
| Arm | Type | Receives |
|---|---|---|
| Usual care group | No intervention | –Infants randomized to this group will receive the present standard of care for weaning respiratory support. This means the attending provider will decide when each infant is ready to be changed from CPAP to nasal cannula and the nasal cannula will be weaned according to an existing unit protocol. |
| Protocol care group | Active comparator | Other: Protocolized weaning of respiratory supportInfants randomized to this group will remain on CPAP until they are at least 32 weeks corrected gestational age or 1250g. At that point, if they meet a set of criteria, they will be transitioned to either 2L nasal cannula if they require supplemental oxygen or room air. |
Who may qualify
- Ages
- 22 to 30 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- babies born at <30 weeks' gestation
- babies who are extubated to non-invasive ventilation by 32 weeks postmenstrual age
Key exclusion criteria (7 listed)
- babies born at <30 weeks' gestation
- requiring less than 2L NC at birth or
- those who are extubated after 32.0 weeks' postmenstrual age
- congenital anomalies
- skeletal disorders
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 |
|---|---|---|
| Protocolized weaning of respiratory supportThe protocolized weaning aims to keep babies on CPAP for a longer period of time and will measure how long it takes babies to wean to 2L nasal cannula support or come off all support (room air, RA). | Other | Protocol care group |
Primary outcome
Time to reach 2L NC or room air
Time frame: up to 3 months
The primary outcome is time (in days) to reach 2L nasal cannula or room air
1 secondary outcome
Compliance to protocol and balancing measures
Time frame: up to 3 months
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 29 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Kelley Z Kovatis, MD principal investigator
Christiana Care Health Services, Inc
Anastasiya Latushko principal investigator
Christiana Care Health Services, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized weaning of respiratory support in people with Bronchopulmonary Dysplasia and Prematurity, run by Christiana Care Health Services 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 2 inclusion and 7 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 Aug 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?
Time to reach 2L NC or room air (time frame: up to 3 months). 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 29 Aug 2024.