Mechanical VentilationPhase 4CPAP-DRNCT01024361
Cpap at Delivery Room for Preterm Infants
A Phase 4 study testing CPAP in people with Mechanical Ventilation and Retinal Disease, run by University of Sao Paulo.
Trial summary
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life. Read more about this study
- Who is it for?
- Ages 1 minute to 15 minutes
- Conditions the study is for
- Mechanical Ventilation, Retinal Disease, Death
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 4
- 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 1 minute to 15 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight 1000g to 1500g
- No major malformations
Who cannot join
- Necessity of intubation
- Maternal decision
About this study
Official title: CPAP Application at Delivery Room at Very Low Birth Weight Infants
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.
Read the detailed description
A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs
- Being tested
- CPAP
- Keywords
- Preterm infants, Nasal CPAP, Delivery room, Newborn
- Medical subject headings
- Retinal Diseases, Death, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Neopuff
CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff
| Study group | Role | What they receive |
|---|---|---|
| Routine | No intervention | Routine protocol of the service |
| CPAP-DR | Experimental | Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necessity of mechanical ventilation and surfactant during the first 5 days of life
Measured: 5 days
Secondary outcomes (7)
Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life
Measured: 15 minutes
Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis
Measured: 30 days
Oxygen use
Measured: 28 days
Oxygen use
Measured: 56 days
Oxygen use
Measured: 36 weeks of corrected age
Retinopathies of prematurity
Measured: Hospital stay
Death during hospitalization
Measured: Hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Francisco E Martinez, MD, Principal investigator, University of sao Paulo at Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024361
- Sponsor's protocol ID
- 120789
- Other IDs
- FAPESP 06/61388-2
- Acronym
- CPAP-DR
- Status last verified
- Dec 2009
- First submitted
- 27 Nov 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Application at Delivery Room at Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01024361
- Acronym / sponsor ID
- CPAP-DR / 120789
- Keywords
- Preterm infants, Nasal CPAP, Delivery room, Newborn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Dec 2009 (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.
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.
Detailed description
A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine | No intervention | –Routine protocol of the service |
| CPAP-DR | Experimental | Device: CPAPInfants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life |
Who may qualify
- Ages
- 1 minute to 15 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth weight 1000g to 1500g
- No major malformations
Key exclusion criteria (2 listed)
- Necessity of intubation
- Maternal decision
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 |
|---|---|---|
| CPAPAlso: NeopuffCPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff | Device | CPAP-DR |
Primary outcome
Necessity of mechanical ventilation and surfactant during the first 5 days of life
Time frame: 5 days
7 secondary outcomes
Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life
Time frame: 15 minutes
Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis
Time frame: 30 days
Oxygen use
Time frame: 28 days
Oxygen use
Time frame: 56 days
Oxygen use
Time frame: 36 weeks of corrected age
Retinopathies of prematurity
Time frame: Hospital stay
Death during hospitalization
Time frame: Hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
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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.
Francisco E Martinez, MD principal investigator
University of sao Paulo at Ribeirão Preto
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP in people with Mechanical Ventilation and Retinal Disease, run by University of Sao Paulo.
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 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: status not confirmed, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Necessity of mechanical ventilation and surfactant during the first 5 days of life (time frame: 5 days). 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 23 Dec 2009.