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insufficient number of subjects
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| Name | Class |
|---|---|
| MS Ramaiah Medical College & Hospitals | OTHER |
| Wellcome Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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] |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6, 12, 24, 48 and 72 hours after treatment commencement |
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | 6, 12, 24, 48 and 72 hours after treatment commencement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G CM Pradeep, MD | MS Ramaiah Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.S. Ramaiah Medical College | Bangalore | Karnataka | 560054 | India |
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There were no wash-out or run-in procedures. No enrolled participant was excluded from the study before randomisation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dolphin Continuous Positive Airway Pressure | Continuous Positive Airway Pressure (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] CPAP: CPAP therapy |
| FG001 | Fisher-Paykel Continuous Positive Airway Pressure | Fisher-Paykel (F&P) Continuous Positive Airway Pressure (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. CPAP: CPAP therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dolphin Continuous Positive Airway Pressure | Continuous Positive Airway Pressure (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] CPAP: CPAP therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Number missing at each time point: 6 hrs: 1 Dolphin (failed), 0 FP 12 hrs: 1 Dolphin (failed), 1 FP (recovered) 24 hrs: 6 Dolphin (2 failed + 4 recovered), 4 FP (all recovered) 48 hrs: 16 Dolphin (3 failed + 13 recovered), 11 FP (1 failed + 10 recovered) 72 hrs: 21 Dolphin (3 failed + 18 recovered), 21 FP (1 failed + 20 recovered) | Posted | Median | Inter-Quartile Range | Percentage of inspired oxygen | 6, 12, 24, 48 and 72 hours after treatment commencement |
|
Adverse event data were collected till hospital discharge or two months of age, whichever is earlier.
One serious adverse events was monitored, death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dolphin CPAP | 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] CPAP: CPAP therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Infections and infestations | Systematic Assessment | As required by the governing ethics committee, death for any reason before hospital discharge was defined as a serious adverse event. Details of the death are reported at Outcome #19. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intubation & Mechanical Ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Intubation and mechanical ventilation after FiO2>=60% |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gaston Arnolda | Arnolda Consulting | +61 2 8068 4963 | gaston.arnolda@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2019 | Sep 8, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 3, 2017 | Oct 14, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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As the machines are physically distinct, blinding of participants, care providers and investigators is not feasible. The assessment of most outcomes cannot therefore be blinded, with one exception: x-rays for neonates with suspected pneumothorax will be provided to a radiologist for independent verification; the radiologist will not be in the nursery and will therefore be blinded to treatment allocation.
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| Respiratory Rate |
Respiratory rate (breaths/minute), measured as a change from baseline |
| 6, 12, 24, 48 and 72 hours after treatment commencement |
| Arterial pH | pH measured as a change from baseline (where 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) | 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) | 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%. | 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. | 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. | 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 | 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:
| 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 | 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 | 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 | 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 | 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 | 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%. | 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 | 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 | From date and time of randomization to date and time of hospital discharge, assessed to a maximum of 2 months of age. |
| BG001 | Fisher-Paykel Continuous Positive Airway Pressure | Fisher-Paykel (F&P) Continuous Positive Airway Pressure (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. CPAP: CPAP therapy |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Birthweight | Mean | Standard Deviation | Grams |
|
| FiO2 at baseline | Median | Inter-Quartile Range | Percentage of inspired oxygen |
|
| SpO2 at baseline | Median | Inter-Quartile Range | Percentage capillary oxygen saturation |
|
| Respiratory rate at baseline | Median | Inter-Quartile Range | Breaths/minute |
|
| pH at baseline | Only 31/51 infants had a blood gas at baseline | Median | Inter-Quartile Range | pH |
|
| Partial pressure of arterial oxygen at baseline | Only 31/51 infants had a blood gas at baseline | Median | Inter-Quartile Range | Torr |
|
| Partial pressure of arterial carbon dioxide at baseline | Only 31/51 infants had a blood gas at baseline | Median | Inter-Quartile Range | Torr |
|
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] CPAP: CPAP therapy |
| OG001 | Fisher-Paykel CPAP | 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. CPAP: CPAP therapy |
|
|
|
| Secondary | 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%). | Number missing: 6 hrs: 1 Dolphin (failed), 0 FP 12 hrs: 1 Dolphin (failed), 1 FP (recovered) 24 hrs: 6 Dolphin (2 failed + 4 recovered), 4 FP (all recovered) 48 hrs: 16 Dolphin (3 failed + 13 recovered), 11 FP (1 failed + 10 recovered) 72 hrs: 21 Dolphin (3 failed + 18 recovered), 21 FP (1 failed + 20 recovered) | Posted | Median | Inter-Quartile Range | Percentage capillary oxygen saturation | 6, 12, 24, 48 and 72 hours after treatment commencement |
|
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|
|
| Secondary | Respiratory Rate | Respiratory rate (breaths/minute), measured as a change from baseline | Number missing (and thus imputed): 6 hrs: 1 Dolphin (failed), 0 FP 12 hrs: 1 Dolphin (failed), 1 FP (recovered) 24 hrs: 6 Dolphin (2 failed + 4 recovered), 4 FP (all recovered) 48 hrs: 16 Dolphin (3 failed + 13 recovered), 11 FP (1 failed + 10 recovered) 72 hrs: 21 Dolphin (3 failed + 18 recovered), 21 FP (1 failed + 20 recovered) | Posted | Median | Inter-Quartile Range | Breaths per minute | 6, 12, 24, 48 and 72 hours after treatment commencement |
|
|
|
|
| Secondary | Arterial pH | pH measured as a change from baseline (where measured) | Only 31/51 infants had a baseline blood gas taken, and only 7 of these had a second or subsequent test, with five of them at 6 hours, two each at 12 and 24 hours and one each at 48 and 72 hours. No statistical testing performed. | Posted | Median | Inter-Quartile Range | pH | 6, 12, 24, 48 and 72 hours after treatment commencement (where available) |
|
|
|
| Secondary | Partial Pressure of Arterial Oxygen (PaO2) | PaO2 measured as a change from baseline (where measured) | Only 31/51 infants had a baseline blood gas taken, and only 7 of these had a second or subsequent test, with five of them at 6 hours, two each at 12 and 24 hours and one each at 48 and 72 hours. No statistical testing performed. | Posted | Median | Inter-Quartile Range | Torr | 6, 12, 24, 48 and 72 hours after treatment commencement (where available) |
|
|
|
| Secondary | Partial Pressure of Arterial Carbon Dioxide (PaCO2) | PaCO2 measured as a change from baseline (where measured) | Only 31/51 infants had a baseline blood gas taken, and only 7 of these had a second or subsequent test, with five of them at 6 hours, two each at 12 and 24 hours and one each at 48 and 72 hours. No statistical testing performed. | Posted | Median | Inter-Quartile Range | Torr | 6, 12, 24, 48 and 72 hours after treatment commencement (where available) |
|
|
|
| Secondary | 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%. | Posted | Count of Participants | Participants | 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. |
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| Secondary | 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. | Posted | Count of Participants | Participants | 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. |
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| Secondary | 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. | Posted | Count of Participants | Participants | 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. |
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| Secondary | CPAP Duration | Duration of CPAP treatment (hours) in infants that do not fail CPAP | Excludes 3 Dolphin and 2 FP randomised infants that failed treatment (escalated to mechanical ventilation) | Posted | Median | Inter-Quartile Range | Hours | 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. |
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| Secondary | Serious Adverse Event | A Serious adverse Event (SAEs) is any untoward medial occurrence that:
| The infant that died recovered after CPAP but was subsequently treated for apnea and a patent ductus arteriosus. Twelve days after CPAP cessation the infant commenced antibiotics for elevated CRP and was intubated and ventilated and died. The Data Safety Monitoring Committee determined that the death was unrelated to treatment group. | Posted | Count of Participants | Participants | From date and time of birth to date and time of hospital discharge, assessed to a maximum of 2 months of age. |
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| Secondary | Sentinel Outcome #1 | Damage to the nasal septum | Posted | Count of Participants | Participants | From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age. |
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| Secondary | Sentinel Outcome #2 | Damage to the nares of the infant | Posted | Count of Participants | Participants | From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age. |
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| Secondary | Sentinel Outcome #3 | Pneumothorax as diagnosed by X-ray | Posted | Count of Participants | Participants | From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age. |
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| Secondary | Sentinel Outcome #4 | Intra-ventricular haemorrhage (IVH), intra-cranial haemorrhage (ICH), or periventricular leukomalacia (PVL) as diagnosed by cranial ultrasound scan | Posted | Count of Participants | Participants | From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age. |
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| Secondary | Sentinel Outcome #5 | FiO2 ≥ 60% to maintain SpO2 at 90-95% for one hour or more, during CPAP treatment | Posted | Count of Participants | Participants | From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age. |
|
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| Secondary | 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%. | Posted | Count of Participants | Participants | From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age. |
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| Secondary | Sentinel Outcome #7 | For infants born at 28+0 to 33+6 weeks' gestation, oxygen dependent at 36 weeks' gestation | Posted | Count of Participants | Participants | From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age. |
|
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|
| Secondary | Sentinel Outcome #8 | Death of the infant before hospitals discharge | The infant that died recovered after CPAP but was subsequently treated for apnoeas and a patent ductus arteriosus. Twelve days after CPAP cessation the infant commenced antibiotics for elevated CRP and was intubated and ventilated and died. The Data Safety Monitoring Committee determined that the death was unrelated to treatment group. | Posted | Count of Participants | Participants | From date and time of randomization to date and time of hospital discharge, assessed to a maximum of 2 months of age. |
|
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|
|
| 1 |
| 26 |
| 1 |
| 26 |
| 4 |
| 26 |
| EG001 | Fisher-Paykel CPAP | 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. CPAP: CPAP therapy | 0 | 25 | 0 | 25 | 2 | 25 |
|
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| Culture confirmed infection | Infections and infestations | Systematic Assessment | Diagnosed with Klebsiella Pneumoniae |
|
Not provided
Not provided
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Change at 12 hours |
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| Change at 24 hours |
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| Change at 48 hours |
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| Change at 72 hours |
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| Change at 12 hours |
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| Change at 24 hours |
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| Change at 48 hours |
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| Change at 72 hours |
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| Change at 12 hours |
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| Change at 24 hours |
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| Change at 48 hours |
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| Change at 72 hours |
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| Change at 12 hours |
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| Change at 24 hours |
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| Change at 48 hours |
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| Change at 72 hours |
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| Change at 12 hours |
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| Change at 24 hours |
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| Change at 48 hours |
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| Change at 72 hours |
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