VentilationNCT01053455
Observational Crossover Study Comparing Oxygenation and Ventilation Using SiPAP Versus CPAP in LBW Infants
An observational study of Ventilation and Respiratory Distress Syndrome, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilation, Respiratory Distress Syndrome
- What is being tested?
- SiPAP
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: low birth weight infants
Who may be able to join
- LBW infant (birth weight <2500 grams)
- Currently on nasal CPAP
- Use of nasal CPAP for >24 hours prior to study initiation
- If history of intubation with mechanical ventilation, patient will be extubated >24 hours prior to study initiation
- FiO2 requirement of 25-50%
Who cannot join
- FiO2 requirement >0.5
- Congenital defects/deformities of the head, pulmonary or cardiovascular systems
- Chromosomal abnormalities/genetic syndromes
- Active medical treatment for symptomatic PDA
- Active medical treatment for culture proven sepsis
- Within 24 hours of invasive surgical procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital and Clinics of MN - St. Paul
Saint Paul, Minnesota, 55102
About this study
Official title: Observational Crossover Study Comparing Oxygenation and Ventilation Using Biphasic CPAP (SiPAP) Versus CPAP to Treat Respiratory Distress in Low Birth Weight Infants
Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.
- Conditions
- Ventilation, Respiratory Distress Syndrome
- Being tested
- SiPAP
- Keywords
- Non-invasive ventilation, SiPAP, CPAP, low birth weight infants, respiratory distress syndrome
- Medical subject headings
- Respiratory Aspiration, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiPAPDevice
biphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP
| Study group | Role | What they receive |
|---|---|---|
| Starting on NCPAP | randomized to start on NCPAP Receives: Device: SiPAP | |
| Starting on SiPAP | randomized to SiPAP Receives: Device: SiPAP |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
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 VentilationStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Lampland, Children's Hospitals and Clinics of Minnesota
- Investigators
- Andrea Lampland, MD, Principal investigator, Childrens Hospitals and Clinics of MN - St. Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053455
- Sponsor's protocol ID
- 0911-106
- Status last verified
- Jun 2012
- First submitted
- 20 Jan 2010
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lampland AL, Plumm B, Worwa C, Meyers P, Mammel MC. Bi-level CPAP does not improve gas exchange when compared with conventional CPAP for the treatment of neonates recovering from respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F31-4. doi: 10.1136/fetalneonatal-2013-305665. Epub 2014 Aug 1.
PubMed 25085943
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Crossover Study Comparing Oxygenation and Ventilation Using Biphasic CPAP (SiPAP) Versus CPAP to Treat Respiratory Distress in Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01053455
- Acronym / sponsor ID
- 0911-106
- Conditions
- Ventilation, Respiratory Distress Syndrome
- Keywords
- Non-invasive ventilation, SiPAP, CPAP, low birth weight infants, respiratory distress syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Jan 2010 (estimated)
- 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.
Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starting on NCPAP | – | Device: SiPAPrandomized to start on NCPAP |
| Starting on SiPAP | – | Device: SiPAPrandomized to SiPAP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- low birth weight infants
Key inclusion criteria (5 listed)
- LBW infant (birth weight <2500 grams)
- Currently on nasal CPAP
- Use of nasal CPAP for >24 hours prior to study initiation
- If history of intubation with mechanical ventilation, patient will be extubated >24 hours prior to study initiation
- FiO2 requirement of 25-50%
Key exclusion criteria (6 listed)
- FiO2 requirement >0.5
- Congenital defects/deformities of the head, pulmonary or cardiovascular systems
- Chromosomal abnormalities/genetic syndromes
- Active medical treatment for symptomatic PDA
- Active medical treatment for culture proven sepsis
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 |
|---|---|---|
| SiPAPbiphasic CPAP (SiPAP) to be alternated in 1 hour blocks with NCPAP | Device | Starting on NCPAP, Starting on SiPAP |
Primary outcome
Not reported in the source record.
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 22 Jun 2012.
- Derived from this study: PubMed 25085943Lampland AL, Plumm B, Worwa C, Meyers P, Mammel MC. Bi-level CPAP does not improve gas exchange when compared with conventional CPAP for the treatment of neonates recovering from respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F31-4. doi: 10.1136/fetalneonatal-2013-305665. Epub 2014 Aug 1.
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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.
Andrea Lampland, MD principal investigator
Childrens Hospitals and Clinics of MN - St. Paul
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 Ventilation and Respiratory Distress Syndrome, run by Children's Hospitals and Clinics of Minnesota 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 5 inclusion and 6 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 22 Jun 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053455, 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 22 Jun 2012; AzTrials last refreshed its copy on 27 Oct 2026.