Non-invasive Ventilatory SupportNCT01861795
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
An observational study of Non-invasive Ventilatory Support and Infant Respiratory Distress Syndrome, run by Takeda at 3 sites in Germany.
Trial summary
The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment. Read more about this study
- Who is it for?
- Ages 27 to 36 weeks
- Conditions the study is for
- Non-invasive Ventilatory Support, Infant Respiratory Distress Syndrome
- What is being tested?
- Preterm Neonates
- How many people
- 40 participants
- Where
- 3 sitesGermany
- Study dates
- Jun 2013to Mar 2014
- 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 27 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates on non-invasive ventilatory support in a hospital setting.
Who may be able to join
- 1. Written, informed consent of both parents or legal guardian(s) obtained (on admission, prior to or after delivery).
- 2. Preterm neonates born at or above 27+0 gestational weeks (GW) who are sufficiently stable on nasal continuous positive airway pressure (CPAP). Upper limit 36+0 GW.
- 3. Participants' minimum weight at birth must be 800 g. Upper weight limit is 2500 g.
- 4. CPAP-positive end-expiratory pressure (PEEP) must be ≥5 cm and ≤ 8 cm H2O. 5. Fraction of oxygen (O2) in ventilator outlet gas flow (FiO2) ≥ 30% to reach saturation goal (SpO2 between 88% and 96%) during the time period from B0 to T0.
Who cannot join
- 1. FiO2 > 50% to reach saturation goal (saturation of peripheral oxygen (SpO2) between 88% and 96%) during the time period from 30 minutes after birth (B0) to 45 minutes after birth (T0).
- 2. Presence of severe respiratory distress syndrome (RDS) necessitating immediate intubation and surfactant rescue at entry into the study, or having necessitated surfactant rescue prior to entry into the study.
- 3. Known life-threatening congenital anomaly or genetic syndrome. 4. Participation in an interventional study in parallel to this observational study.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: An Oligo-center Observational Study to Collect Data in Preterm Neonates Born at or Above 27+0 Weeks of Gestational Age Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.
Read the detailed description
The objective of this study is to collect data on vital signs, oxygen requirements and other data in preterm infants who are breathing stably on non-invasive ventilatory support. The data obtained during this study will be used to compare data obtained in a future study that will add a new medicinal product in combination with non-invasive ventilatory support to accelerate lung development in preterm infants.
The study will enroll approximately 40 patients. Participants will not be receiving any investigational medicinal product or device in this study.
All participants will have vital signs, oxygen requirements and other data collected continuously throughout the study.
This multi-centre trial will be conducted in Germany. The overall time to participate in this study is up to 10 weeks. Participants will be observed until they reach 36 weeks of gestational age or until they are discharged from the hospital.
- Being tested
- Preterm Neonates
- Keywords
- Drug therapy
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm NeonatesOther
Preterm Neonates
| Study group | Role | What they receive |
|---|---|---|
| Preterm Neonates | Preterm neonates born at or above 27+0 weeks of gestational age sufficiently stable on nasal continuous positive airway pressure (CPAP) will be treated by standard of care. Receives: Other: Preterm Neonates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time and failure-adjusted Area Under the Curve (AUC) from Time 0 (T0) to 98 hours after T0 (T47) (AUCT0-T47adjusted) of fraction of inspired oxygen (FiO2)
Fraction of inspired oxygen (FiO2) is the amount of oxygen in the ventilator outlet gas flow.
Measured: Beginning of the Intensive observation phase (T0; approximately 45 minutes after birth) to 98 hours after T0
Secondary outcomes (13)
Time with optimal saturation of peripheral oxygen (SpO2) of 88% to 96%
Saturation of peripheral oxygen is the amount of oxygen bound to hemoglobin in the blood expressed as a percentage of the maximal binding capacity. It will be measured with a pulse oximeter.
Measured: T0 and at 0.25, 0.5, 0.75 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 4, 4.25. 4.5, 4.74, 5, 5.25, 5.75, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 hours
Continuous positive airway pressure (CPAP)-failure necessitating intubation and mechanical ventillation and/or surfactant instillation during observation period from T0 to 98 hours
CPAP failure is reached when FiO2 ≥ 50% is need for more than 15 minutes to reach 90% saturation of peripheral oxygen (SpO2).
Measured: T0 to 98 hours
Percentage of participants requiring instillation of an approved surfactant preparation
Measured: Gestational week (GW) 36+6 days
Percentage of participants with bronchopulmonary dysplasia (BPD) at GW 36
Bronchopulmonary dysplasia (BPD) is defined as a lung injury in preterm neonates resulting from oxygen toxicity and/or mechanical ventilation (elevated air pressure).
Measured: Gestational Week 36
Respiratory rate over time
Measured: T0 to Gestational Week 36
Percentage of participants with a positive room-air challenge test at Gestational Week 36
The room-air challenge test is defined as a weaning attempt allowing the participant to breath non-pressurized room air for 30 minutes. If a blood oxygen saturation of ≥90% is achieved during weaning, the weaning was successful and patients are considered to be free of bronchopulmonary dysplasia and need no further ventilation support.
Measured: Gestational Week 36
Mortality rate
Measured: T0 to Gestational Week 36+6 days
Time under Continuous Positive Airway Pressure ventilatory support
Measured: T0 to Gestational Week 36+6 days
Time of additional oxygen demand (FiO2 > 21%)
Measured: T0 to Gestational Week 36+6 days
Time in neonatal intensive care unit (NICU) or intermediate care unit (IMCU)
Measured: T0 to Gestational Week 36+6 days
Time of intubation for mechanical ventilation
Measured: T0 to Gestational Week 36+6 days
Time on any ventilation support
Any ventilation support includes continuous positive airway pressure (CPAP), manual support and intubation.
Measured: T0 to Gestational Week 36+6 days
Days in hospital
Measured: From T0 to Gestational Week 36+6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive Ventilatory SupportStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861795
- Sponsor's protocol ID
- RS-7261-201-RD
- Other IDs
- U1111-1141-9396
- Status last verified
- Aug 2014
- First submitted
- 26 Apr 2013
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Oligo-center Observational Study to Collect Data in Preterm Neonates Born at or Above 27+0 Weeks of Gestational Age Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
- ClinicalTrials.gov ID
- NCT01861795
- Acronym / sponsor ID
- RS-7261-201-RD
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 May 2013 (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 purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.
Detailed description
The objective of this study is to collect data on vital signs, oxygen requirements and other data in preterm infants who are breathing stably on non-invasive ventilatory support. The data obtained during this study will be used to compare data obtained in a future study that will add a new medicinal product in combination with non-invasive ventilatory support to accelerate lung development in preterm infants.
The study will enroll approximately 40 patients. Participants will not be receiving any investigational medicinal product or device in this study.
All participants will have vital signs, oxygen requirements and other data collected continuously throughout the study.
This multi-centre trial will be conducted in Germany. The overall time to participate in this study is up to 10 weeks. Participants will be observed until they reach 36 weeks of gestational age or until they are discharged from the hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm Neonates | – | Other: Preterm NeonatesPreterm neonates born at or above 27+0 weeks of gestational age sufficiently stable on nasal continuous positive airway pressure (CPAP) will be treated by standard of care. |
Who may qualify
- Ages
- 27 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates on non-invasive ventilatory support in a hospital setting.
Key inclusion criteria (4 listed)
- 1. Written, informed consent of both parents or legal guardian(s) obtained (on admission, prior to or after delivery).
- 2. Preterm neonates born at or above 27+0 gestational weeks (GW) who are sufficiently stable on nasal continuous positive airway pressure (CPAP). Upper limit 36+0 GW.
- 3. Participants' minimum weight at birth must be 800 g. Upper weight limit is 2500 g.
- 4. CPAP-positive end-expiratory pressure (PEEP) must be ≥5 cm and ≤ 8 cm H2O. 5. Fraction of oxygen (O2) in ventilator outlet gas flow (FiO2) ≥ 30% to reach saturation goal (SpO2 between 88% and 96%) during the time period from B0 to T0.
Key exclusion criteria (3 listed)
- 1. FiO2 > 50% to reach saturation goal (saturation of peripheral oxygen (SpO2) between 88% and 96%) during the time period from 30 minutes after birth (B0) to 45 minutes after birth (T0).
- 2. Presence of severe respiratory distress syndrome (RDS) necessitating immediate intubation and surfactant rescue at entry into the study, or having necessitated surfactant rescue prior to entry into the study.
- 3. Known life-threatening congenital anomaly or genetic syndrome. 4. Participation in an interventional study in parallel to this observational study.
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 |
|---|---|---|
| Preterm NeonatesPreterm Neonates | Other | Preterm Neonates |
Primary outcome
Time and failure-adjusted Area Under the Curve (AUC) from Time 0 (T0) to 98 hours after T0 (T47) (AUCT0-T47adjusted) of fraction of inspired oxygen (FiO2)
Time frame: Beginning of the Intensive observation phase (T0; approximately 45 minutes after birth) to 98 hours after T0
Fraction of inspired oxygen (FiO2) is the amount of oxygen in the ventilator outlet gas flow.
13 secondary outcomes
Time with optimal saturation of peripheral oxygen (SpO2) of 88% to 96%
Time frame: T0 and at 0.25, 0.5, 0.75 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 4, 4.25. 4.5, 4.74, 5, 5.25, 5.75, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 hours
Continuous positive airway pressure (CPAP)-failure necessitating intubation and mechanical ventillation and/or surfactant instillation during observation period from T0 to 98 hours
Time frame: T0 to 98 hours
Percentage of participants requiring instillation of an approved surfactant preparation
Time frame: Gestational week (GW) 36+6 days
Percentage of participants with bronchopulmonary dysplasia (BPD) at GW 36
Time frame: Gestational Week 36
Respiratory rate over time
Time frame: T0 to Gestational Week 36
Percentage of participants with a positive room-air challenge test at Gestational Week 36
Time frame: Gestational Week 36
Mortality rate
Time frame: T0 to Gestational Week 36+6 days
Time under Continuous Positive Airway Pressure ventilatory support
Time frame: T0 to Gestational Week 36+6 days
Time of additional oxygen demand (FiO2 > 21%)
Time frame: T0 to Gestational Week 36+6 days
Time in neonatal intensive care unit (NICU) or intermediate care unit (IMCU)
Time frame: T0 to Gestational Week 36+6 days
Time of intubation for mechanical ventilation
Time frame: T0 to Gestational Week 36+6 days
Time on any ventilation support
Time frame: T0 to Gestational Week 36+6 days
Days in hospital
Time frame: From T0 to Gestational Week 36+6 days
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 Aug 2014.
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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.
Medical Director study director
Takeda
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Ventilatory Support and Infant Respiratory Distress Syndrome, run by Takeda at 3 sites in Germany.
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 4 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: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does the primary outcome measure?
Time and failure-adjusted Area Under the Curve (AUC) from Time 0 (T0) to 98 hours after T0 (T47) (AUCT0-T47adjusted) of fraction of inspired oxygen (FiO2) (time frame: Beginning of the Intensive observation phase (T0; approximately 45 minutes after birth) to 98 hours after T0). 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 22 Aug 2014.