Respiratory Distress Syndrome, NewbornNCT03121612
Comparison of CPAP Machines With Reusable vs Disposable Circuits
A study testing CPAP in people with Respiratory Distress Syndrome, Newborn, run by Medical Technology Transfer and Services Hong Kong Ltd at 1 site in India.
Trial summary
The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 1 minute to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2017to 15 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at Ramaiah Medical College hospital ('inborn infants');
- Infants born elsewhere, and admitted to Ramaiah Medical College hospital under 6 hours of age ("outborn infants");
- Infants with a gestational age at birth (weeks +days) in the range ≥ 28+0 to ≤ 36+6;
- Infants thought to have RDS (clinically diagnosed after onset of respiratory distress <6 hours of age, sometimes confirmed by X-ray showing homogenous bilateral opacity) who would routinely be provided CPAP therapy; and
- Infants <24 hours old at the time of fulfilling other inclusion criteria.
Who cannot join
- Infants with a 1-minute Apgar score <3 (as a marker of severe birth asphyxia);
- Infants who received MV prior to randomisation;
- Infants with suspected meconium aspiration syndrome will be excluded to avoid any imbalance in this condition across groups;
- Infants clinically suspected to have another specified serious condition as their main disease process, diagnosed prior to randomisation, specifically: cardiac anomaly, other congenital malformation with respiratory sequelae, septicaemia, pulmonary haemorrhage, pneumothorax, meningitis, poor respiratory effort or recurrent apnoea, or brain haemorrhage (IVH Grades III or IV);
- Infants who have an airway abnormality precluding the use of the standard CPAP interface proposed for this study (e.g., Pierre-Robin sequence, cleft lip or cleft palate) or who have a neuromuscular condition that interferes with respiration;
- Any infant whose treating clinician believes should not be randomised due to some other condition, or for any other reason (reason to be documented).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial Comparing CPAP Machines With Reusable vs Disposable Circuits
The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress syndrome. The assessment will compare a comprehensive list of physiological parameters over the first 72 hours of treatment, and will also monitor rates of side effects and adverse events. The null hypothesis is that infants treated on the two categories of machine (reusable vs disposable) will not differ in relation to key physiological parameters by more than 0.63 standard deviations.
Read the detailed description
One of the commonest sources of serious newborn morbidity and mortality is difficulty with breathing. When this occurs, three main types of supportive therapy are available to increase the provision of oxygen to cells: a) passive provision of oxygen-enriched gases (i.e., higher than the 21% O2 found in the earth's atmosphere) through tubes in the nostrils, or by putting a hood over the baby's head and enriching the gases under that hood; b) provision of room air or oxygen-enriched gasses under pressure, frequently performed using a method called continuous positive airway pressure [CPAP] therapy; and/or c) by using a machine that is able to breath on behalf of the baby, most commonly referred to as mechanical ventilation [MV].
Passive therapy is the least invasive method but is also of limited benefit, particularly for infants born preterm. CPAP is more effective than passive methods because continuous distending pressure to the lungs allows better oxygen exchange; however, the distending pressure increases the risk of damage to the lung. MV is the only method that can be used on babies without a neurological impulse to breath, but the mechanical breathing action can damage the lungs, and MV is usually provided through a tube inserted into the lungs which increases the risk of lung infection; MV machines are also significantly more expensive than CPAP machines.
In high resource settings, CPAP is now the preferred method of providing oxygen for infants where passive therapy is insufficient, because of the lower infection risk, lower risk of lung damage, and relative ease of clinical care. CPAP is increasingly recommended for low resource settings, but the CPAP machines used in high resource settings are too expensive for low resource settings due to high-priced consumables ($US50-200/baby), and are usually unusable in low resource settings because they require 'medical air' (clean air in a cylinder, or through a piped wall system) with which to blend 100% oxygen. Low cost 'indigenous' machines ('jury-rigged' by hospital staff) have also been developed, but these do not provide the heated, humidified and blended gasses, that are recommended for CPAP.
This study seeks to evaluate a novel CPAP machine that provides heated, humidified, blended gasses, in line with recommendations for high-resource settings, while massively reducing costs by including re-usable tube sets and humidifiers that can be autoclaved, and with an on-board air-compressor to allow use in a broader range of clinical settings. By reducing the cost per CPAP treatment, such a machine can dramatically increase the number of hospitals in low resource settings that can provide high quality CPAP treatment.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- CPAP
- Keywords
- RDS
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP therapy
| Study group | Role | What they receive |
|---|---|---|
| Dolphin CPAP | Experimental | CPAP machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. [Also includes built-in Massimo pulse oximeter, though this is not used for this study, to prevent differential measurement error in SpO2 measurement] Receives: Device: CPAP |
| Fisher-Paykel CPAP | Active comparator | Fisher-Paykel (F\&P) CPAP machine with separate oxygen and medical air intakes, with third-party FP-compliant blender, and F\&P blender, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
FiO2
Fraction of inspired oxygen (FiO2), measured as a change from baseline as shown on the two machines.
Note. Outcome contaminated. An SpO2 target of 90-95% reflects currently recommended practice for neonates; when SpO2 exceeds the target, FiO2 should be reduced. The majority of readings were at SpO2 > 95%, so FiO2 for these SpO2 readings reflects oxygen provided, not oxygen required to achieve the recommended SpO2 target range (i.e., the FiO2 provided was excessive, by an unknown amount).
Measured: 6, 12, 24, 48 and 72 hours after treatment commencement
Secondary outcomes (18)
SpO2
Oxygen saturation by pulse oximetry (SpO2), measured as a change from baseline
Note. Outcome contaminated. An SpO2 target of 90-95% reflects currently recommended practice for neonates. The majority of readings were at SpO2 > 95%, above SpO2 target (90-95%).
Measured: 6, 12, 24, 48 and 72 hours after treatment commencement
Respiratory Rate
Respiratory rate (breaths/minute), measured as a change from baseline
Measured: 6, 12, 24, 48 and 72 hours after treatment commencement
Arterial pH
pH measured as a change from baseline (where measured)
Measured: 6, 12, 24, 48 and 72 hours after treatment commencement (where available)
Partial Pressure of Arterial Oxygen (PaO2)
PaO2 measured as a change from baseline (where measured)
Measured: 6, 12, 24, 48 and 72 hours after treatment commencement (where available)
Partial Pressure of Arterial Carbon Dioxide (PaCO2)
PaCO2 measured as a change from baseline (where measured)
Measured: 6, 12, 24, 48 and 72 hours after treatment commencement (where available)
Number of Participants Who Died or Needed Intubation and/or Mechanical Ventilation, as a Measure of CPAP Failure, Measured to Date and Time of Cessation of CPAP Treatment
Death or need for intubation and mechanical ventilation as demonstrated by an FiO2 requirement ≥ 60% for ≥ 1 hour to maintain SpO2 at 90-95%
Note. An SpO2 target of 90-95% reflects currently recommended practice for neonates. FiO2 and SpO2 at time of intubation and ventilation not separately recorded, so we report this endpoint as recorded by clinicians, assuming that they have verified FiO2 [≥ 60% for ≥ 1 hour] and SpO2 [targeting 90-95%] requirements at the time of intubation and ventilation. If SpO2 was actually >95% (not 90-95%) at the time of intubation and ventilation, then FiO2 would be higher than required to meet the target range, by an unknown amount (possibly not meeting the FiO2 threshold of ≥ 60% for ≥ 1 hour, required to justify intubation and ventilation). We note this potential source of contamination because the results of Outcome #2 show that the majority of SpO2 readings were >95%.
Measured: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.
Surfactant Provided When FiO2 > 40% to Maintain SpO2 at 90-95% for ≥ 30 Minutes, With Respiratory Distress Syndrome Confirmed by Chest X-Ray
Surfactant provided when FiO2 > 40% to maintain SpO2 at 90-95% for ≥ 30 minutes, with Respiratory Distress Syndrome confirmed by chest X-Ray
Note that endpoint likely corrupted because SpO2 was not routinely targeting 90-95%, and large number of infants received surfactant before achieving >40% or without having x-ray confirmation of RDS.
Measured: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.
CPAP Failure or Surfactant Provision
Outcomes 6 or 7
Note that endpoint likely corrupted because SpO2 was not routinely targeting 90-95%, and large number of infants received surfactant before achieving >40% or without having x-ray confirmation of RDS.
Measured: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.
CPAP Duration
Duration of CPAP treatment (hours) in infants that do not fail CPAP
Measured: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.
Serious Adverse Event
A Serious adverse Event (SAEs) is any untoward medial occurrence that:
- Results in death;
- Is life-threatening; [NOTE: the term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.]
- Requires inpatient hospitalisation or prolongation of existing hospitalisation;
- Results in persistent or significant disability/incapacity, or
- Is a congenital anomaly/birth defect
Measured: From date and time of birth to date and time of hospital discharge, assessed to a maximum of 2 months of age.
Sentinel Outcome #1
Damage to the nasal septum
Measured: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #2
Damage to the nares of the infant
Measured: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #3
Pneumothorax as diagnosed by X-ray
Measured: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #4
Intra-ventricular haemorrhage (IVH), intra-cranial haemorrhage (ICH), or periventricular leukomalacia (PVL) as diagnosed by cranial ultrasound scan
Measured: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #5
FiO2 ≥ 60% to maintain SpO2 at 90-95% for one hour or more, during CPAP treatment
Measured: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #6
Intubation and mechanical ventilation
Note. An SpO2 target of 90-95% reflects currently recommended practice for neonates. FiO2 and SpO2 at time of intubation and ventilation not separately recorded, so we report this endpoint as recorded by clinicians, assuming that they have verified FiO2 [≥ 60% for ≥ 1 hour] and SpO2 [targeting 90-95%] requirements at the time of intubation and ventilation. If SpO2 was actually >95% (not 90-95%) at the time of intubation and ventilation, then FiO2 would be higher than required to meet the target range, by an unknown amount (possibly not meeting the FiO2 threshold of ≥ 60% for ≥ 1 hour, required to justify intubation and ventilation). We note this potential source of contamination because the results of Outcome #2 show that the majority of SpO2 readings were >95%.
Measured: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #7
For infants born at 28+0 to 33+6 weeks' gestation, oxygen dependent at 36 weeks' gestation
Measured: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #8
Death of the infant before hospitals discharge
Measured: From date and time of randomization to date and time of hospital discharge, assessed to a maximum of 2 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Aug 2017
- Primary completion15 Aug 2018
- Study completion15 Oct 2018
Why it stopped: insufficient number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Technology Transfer and Services Hong Kong Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MS Ramaiah Medical College & Hospitals, Wellcome Trust
- Responsible party
- Principal investigator, Dr. Pradeep GCM, MS Ramaiah Medical College & Hospitals
- Investigators
- G CM Pradeep, MD, Principal investigator, MS Ramaiah Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121612
- Sponsor's protocol ID
- MTTS-01-2017
- Status last verified
- Nov 2019
- First submitted
- 12 Feb 2017
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing CPAP Machines With Reusable vs Disposable Circuits
- ClinicalTrials.gov ID
- NCT03121612
- Acronym / sponsor ID
- MTTS-01-2017
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- RDS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient number of subjects
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical Technology Transfer and Services Hong Kong LtdIndustry (pharma, biotech, devices)
- Collaborators
- MS Ramaiah Medical College & Hospitals, Wellcome Trust
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress syndrome. The assessment will compare a comprehensive list of physiological parameters over the first 72 hours of treatment, and will also monitor rates of side effects and adverse events. The null hypothesis is that infants treated on the two categories of machine (reusable vs disposable) will not differ in relation to key physiological parameters by more than 0.63 standard deviations.
Detailed description
One of the commonest sources of serious newborn morbidity and mortality is difficulty with breathing. When this occurs, three main types of supportive therapy are available to increase the provision of oxygen to cells: a) passive provision of oxygen-enriched gases (i.e., higher than the 21% O2 found in the earth's atmosphere) through tubes in the nostrils, or by putting a hood over the baby's head and enriching the gases under that hood; b) provision of room air or oxygen-enriched gasses under pressure, frequently performed using a method called continuous positive airway pressure [CPAP] therapy; and/or c) by using a machine that is able to breath on behalf of the baby, most commonly referred to as mechanical ventilation [MV].
Passive therapy is the least invasive method but is also of limited benefit, particularly for infants born preterm. CPAP is more effective than passive methods because continuous distending pressure to the lungs allows better oxygen exchange; however, the distending pressure increases the risk of damage to the lung. MV is the only method that can be used on babies without a neurological impulse to breath, but the mechanical breathing action can damage the lungs, and MV is usually provided through a tube inserted into the lungs which increases the risk of lung infection; MV machines are also significantly more expensive than CPAP machines.
In high resource settings, CPAP is now the preferred method of providing oxygen for infants where passive therapy is insufficient, because of the lower infection risk, lower risk of lung damage, and relative ease of clinical care. CPAP is increasingly recommended for low resource settings, but the CPAP machines used in high resource settings are too expensive for low resource settings due to high-priced consumables ($US50-200/baby), and are usually unusable in low resource settings because they require 'medical air' (clean air in a cylinder, or through a piped wall system) with which to blend 100% oxygen. Low cost 'indigenous' machines ('jury-rigged' by hospital staff) have also been developed, but these do not provide the heated, humidified and blended gasses, that are recommended for CPAP.
This study seeks to evaluate a novel CPAP machine that provides heated, humidified, blended gasses, in line with recommendations for high-resource settings, while massively reducing costs by including re-usable tube sets and humidifiers that can be autoclaved, and with an on-board air-compressor to allow use in a broader range of clinical settings. By reducing the cost per CPAP treatment, such a machine can dramatically increase the number of hospitals in low resource settings that can provide high quality CPAP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dolphin CPAP | Experimental | Device: CPAPCPAP machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. [Also includes built-in Massimo pulse oximeter, though this is not used for this study, to prevent differential measurement error in SpO2 measurement] |
| Fisher-Paykel CPAP | Active comparator | Device: CPAPFisher-Paykel (F\&P) CPAP machine with separate oxygen and medical air intakes, with third-party FP-compliant blender, and F\&P blender, delivering heated humidified blended gases through a Fisher-Paykel nasal mask. |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants born at Ramaiah Medical College hospital ('inborn infants');
- Infants born elsewhere, and admitted to Ramaiah Medical College hospital under 6 hours of age ("outborn infants");
- Infants with a gestational age at birth (weeks +days) in the range ≥ 28+0 to ≤ 36+6;
- Infants thought to have RDS (clinically diagnosed after onset of respiratory distress <6 hours of age, sometimes confirmed by X-ray showing homogenous bilateral opacity) who would routinely be provided CPAP therapy; and
- Infants <24 hours old at the time of fulfilling other inclusion criteria.
Key exclusion criteria (6 listed)
- Infants with a 1-minute Apgar score <3 (as a marker of severe birth asphyxia);
- Infants who received MV prior to randomisation;
- Infants with suspected meconium aspiration syndrome will be excluded to avoid any imbalance in this condition across groups;
- Infants clinically suspected to have another specified serious condition as their main disease process, diagnosed prior to randomisation, specifically: cardiac anomaly, other congenital malformation with respiratory sequelae, septicaemia, pulmonary haemorrhage, pneumothorax, meningitis, poor respiratory effort or recurrent apnoea, or brain haemorrhage (IVH Grades III or IV);
- Infants who have an airway abnormality precluding the use of the standard CPAP interface proposed for this study (e.g., Pierre-Robin sequence, cleft lip or cleft palate) or who have a neuromuscular condition that interferes with respiration;
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 |
|---|---|---|
| CPAPCPAP therapy | Device | Dolphin CPAP, Fisher-Paykel CPAP |
Primary outcome
FiO2
Time frame: 6, 12, 24, 48 and 72 hours after treatment commencement
Fraction of inspired oxygen (FiO2), measured as a change from baseline as shown on the two machines. Note. Outcome contaminated. An SpO2 target of 90-95% reflects currently recommended practice for neonates; when SpO2 exceeds the target, FiO2 should be reduced. The majority of readings were at SpO2 > 95%, so FiO2 for these SpO2 readings reflects oxygen provided, not oxygen required to achieve the recommended SpO2 target range (i.e., the FiO2 provided was excessive, by an unknown amount).
18 secondary outcomes
SpO2
Time frame: 6, 12, 24, 48 and 72 hours after treatment commencement
Respiratory Rate
Time frame: 6, 12, 24, 48 and 72 hours after treatment commencement
Arterial pH
Time frame: 6, 12, 24, 48 and 72 hours after treatment commencement (where available)
Partial Pressure of Arterial Oxygen (PaO2)
Time frame: 6, 12, 24, 48 and 72 hours after treatment commencement (where available)
Partial Pressure of Arterial Carbon Dioxide (PaCO2)
Time frame: 6, 12, 24, 48 and 72 hours after treatment commencement (where available)
Number of Participants Who Died or Needed Intubation and/or Mechanical Ventilation, as a Measure of CPAP Failure, Measured to Date and Time of Cessation of CPAP Treatment
Time frame: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.
Surfactant Provided When FiO2 > 40% to Maintain SpO2 at 90-95% for ≥ 30 Minutes, With Respiratory Distress Syndrome Confirmed by Chest X-Ray
Time frame: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.
CPAP Failure or Surfactant Provision
Time frame: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.
CPAP Duration
Time frame: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.
Serious Adverse Event
Time frame: From date and time of birth to date and time of hospital discharge, assessed to a maximum of 2 months of age.
Sentinel Outcome #1
Time frame: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #2
Time frame: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #3
Time frame: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #4
Time frame: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #5
Time frame: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #6
Time frame: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #7
Time frame: From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.
Sentinel Outcome #8
Time frame: From date and time of randomization to date and time of hospital discharge, assessed to a maximum of 2 months of age.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
G CM Pradeep, MD principal investigator
MS Ramaiah Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Respiratory Distress Syndrome, Newborn, run by Medical Technology Transfer and Services Hong Kong Ltd at 1 site in India.
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: stopped early, as of the sponsor's last update on 20 Nov 2019. 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 India. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
FiO2 (time frame: 6, 12, 24, 48 and 72 hours after treatment commencement). 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 20 Nov 2019.