Respiratory Distress SyndromePhase 4NCT02887924
SLI MANEUVER and RESPIRATORY MORBIDITIES
A Phase 4 study testing Neopuff; Fisher and Paykel, Auckland, New Zealand in people with Respiratory Distress Syndrome, run by Zekai Tahir Burak Women's Health Research and Education Hospital.
Trial summary
Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group, application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards in preterm infants at high risk for RDS would reduce the need for intubation and mechanical ventilation in early period and… Read more about this study
- Who is it for?
- Ages Up to 3 minutes
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Neopuff; Fisher and Paykel, Auckland, New Zealand
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Sep 2017
- 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 Up to 3 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included.
Who cannot join
- Presence of major congenital anomaly,
- Patients with hydrops fetalis and pulmonary hypoplasia
- Consent not provided or refused
About this study
Official title: THE EFFECT OF SUSTAINED LUNG INFLATION MANEUVER APPLIED THROUGH NASAL PRONG ON EARLY AND LATE RESPIRATORY MORBIDITIES IN PRETERM INFANTS
Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group, application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards in preterm infants at high risk for RDS would reduce the need for intubation and mechanical ventilation in early period and ultimately will improve respiratory outcomes.
Read the detailed description
Primary Outcome Measures:
Surfactant need, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Secondary Outcome Measures:
- Heart rate, fractional inspiratory oxygen, CPAP pressure and oxygen saturation within the first 72 hours of life in preterm infants
- Total non-invasive, invasive respiratory support time
- The presence of and the degree of BPD (Bronchopulmonary dysplasia)
- Premature morbidities such as PDA (patent ductus arteriosus), IVH (intraventricular hemorrhage), NEC (necrotizing enterocolitis), ROP (retinopathy of prematurity)
- Feeding intolerance, reaching birth weight and transition to full oral feeding time
Study Design Randomization Group 1: Group that received SLI maneuver immediately after birth followed by nCPAP.
Group 2: Group that received nCPAP after birth. Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.
Patients will be observed for 5-10 seconds in terms of cardiorespiratory functions following SLI maneuver. If respiratory failure continues during nCPAP (such as apnea, gasping) and/or heart rate is > 60 / min but < 100 / min , SLI maneuver will be repeated at the same pressure for the same time period. If heart rate > 60 / min but <100 / min persists after the second SLI maneuver, resuscitation will be applied in line with the guidelines of American Academy of Pediatrics.
The control group of infants will receive nCPAP support at 5 cm H2O pressure and be supported in line with the guidelines of American Academy of Pediatrics.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Neopuff; Fisher and Paykel, Auckland, New Zealand
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neopuff; Fisher and Paykel, Auckland, New ZealandDevice
Also called SUSTAINED LUNG INFLATION MANEUVER
Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | SLI group In this group the preterm infants will receive sustained lung inflation (SLI) via short binasal prongs in the delivery room. Receives: Device: Neopuff; Fisher and Paykel, Auckland, New Zealand |
| group 2 | Placebo comparator | Preterm infants will be assisted in the delivery room without sustained lung inflation. Receives: Device: Neopuff; Fisher and Paykel, Auckland, New Zealand |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical ventilation requirement
Surfactant requirement, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887924
- Sponsor's protocol ID
- 12082016
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF SUSTAINED LUNG INFLATION MANEUVER APPLIED THROUGH NASAL PRONG ON EARLY AND LATE RESPIRATORY MORBIDITIES IN PRETERM INFANTS
- ClinicalTrials.gov ID
- NCT02887924
- Acronym / sponsor ID
- 12082016
- Conditions
- Respiratory Distress Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 2 Sep 2016 (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.
Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group, application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards in preterm infants at high risk for RDS would reduce the need for intubation and mechanical ventilation in early period and ultimately will improve respiratory outcomes.
Detailed description
Primary Outcome Measures:
Surfactant need, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Secondary Outcome Measures:
- Heart rate, fractional inspiratory oxygen, CPAP pressure and oxygen saturation within the first 72 hours of life in preterm infants
- Total non-invasive, invasive respiratory support time
- The presence of and the degree of BPD (Bronchopulmonary dysplasia)
- Premature morbidities such as PDA (patent ductus arteriosus), IVH (intraventricular hemorrhage), NEC (necrotizing enterocolitis), ROP (retinopathy of prematurity)
- Feeding intolerance, reaching birth weight and transition to full oral feeding time
Study Design Randomization Group 1: Group that received SLI maneuver immediately after birth followed by nCPAP.
Group 2: Group that received nCPAP after birth. Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.
Patients will be observed for 5-10 seconds in terms of cardiorespiratory functions following SLI maneuver. If respiratory failure continues during nCPAP (such as apnea, gasping) and/or heart rate is > 60 / min but < 100 / min , SLI maneuver will be repeated at the same pressure for the same time period. If heart rate > 60 / min but <100 / min persists after the second SLI maneuver, resuscitation will be applied in line with the guidelines of American Academy of Pediatrics.
The control group of infants will receive nCPAP support at 5 cm H2O pressure and be supported in line with the guidelines of American Academy of Pediatrics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Device: Neopuff; Fisher and Paykel, Auckland, New ZealandSLI group In this group the preterm infants will receive sustained lung inflation (SLI) via short binasal prongs in the delivery room. |
| group 2 | Placebo comparator | Device: Neopuff; Fisher and Paykel, Auckland, New ZealandPreterm infants will be assisted in the delivery room without sustained lung inflation. |
Who may qualify
- Ages
- Up to 3 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included.
Key exclusion criteria (3 listed)
- Presence of major congenital anomaly,
- Patients with hydrops fetalis and pulmonary hypoplasia
- Consent not provided or refused
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 |
|---|---|---|
| Neopuff; Fisher and Paykel, Auckland, New ZealandAlso: SUSTAINED LUNG INFLATION MANEUVERFollowing the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied. | Device | group 1, group 2 |
Primary outcome
mechanical ventilation requirement
Time frame: 72 hours
Surfactant requirement, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neopuff; Fisher and Paykel, Auckland, New Zealand in people with Respiratory Distress Syndrome, run by Zekai Tahir Burak Women's Health Research and Education Hospital.
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 1 inclusion and 3 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 13 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
mechanical ventilation requirement (time frame: 72 hours). 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 13 Sep 2016.