PrematurityNCT02901652
NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome
A study testing noninvasive respiratory support devices in people with Prematurity and Respiratory Distress Syndrome, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Purpose is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with… Read more about this study
- Who is it for?
- Ages 1 hour to 3 days
- Conditions the study is for
- Prematurity, Respiratory Distress Syndrome
- What is being tested?
- noninvasive respiratory support devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2016to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 3 days
- 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
- Major congenital anomalies
- Presence of cardiovascular instability
- Intubation at admission to the NICU
- Consent not provided or refused
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching
Ankara, 06230
Mehmet Buyuktiryaki, MD, +905054525576, mbuyuktiryaki@yahoo.com
About this study
Official title: Comparison of Nasal Intermittent Positive Airway Pressure and Nasal Bi-level Positive Airway Pressure Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
Purpose is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Read the detailed description
Purpose is to compare introduction of NIPPV and nBiPAP in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Method
Primary Outcome Measures:
In NIPPV and BIPAP groups, comparison of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life
Secondary Outcome Measures:
- Compare patients' need of total duration of invasive and non-invasive respiratory support and the duration of free oxygen
- Compare oxygen need in postnatal day 28 and week 36
- Compare the presence and severity of BPD (Bronchopulmonary dysplasia)
- Compare premature morbidities such as PDA (patent ductus arteriosus), IVH (intraventricular haemorrhage), NEC (necrotizing enterocolitis), ROP (retinopathy of prematurity)
- Compare feeding intolerance, reaching birth weight and transition to full oral feeding time, hospitalization period
- Compare their neurodevelopment in postnatal age 2
Study Design In NIPPV group; non-synchronous mode will be used, and they will be titrated between FiO2: 021-0.50 in a respiratory rate of 20-40 / min, peak inspiratory pressure (PIP): 15-20 end-expiratory pressure (PEEP):5-6 cm H2O and target oxygen saturation: 90-95 %. In nBiPAP group; they will be titrated between 021-0.50, in non-synchronized PEEP:6 H2O, pressure amplitude: 3 cm H2O, FiO2 target oxygen saturation of 90-95 %.
Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.
Non-invasive respiratory support failure is set as follows:
- FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
- Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
- Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
- Severe respiratory distress,
- Pulmonary haemorrhage and cardiopulmonary arrest.
- Conditions
- Prematurity, Respiratory Distress Syndrome
- Being tested
- noninvasive respiratory support devices
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive respiratory support devicesDevice
| Study group | Role | What they receive |
|---|---|---|
| NIPPV | Active comparator | noninvasive respiratory support devices
This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment. Receives: Device: noninvasive respiratory support devices |
| BİPAP | Active comparator | noninvasive respiratory support devices
This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment. Receives: Device: noninvasive respiratory support devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
surfactant requirement
surfactant requirement within the first 72 hours of life
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 posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- 325 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
- Investigators
- Suna Oğuz, MD, Study director, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901652
- Sponsor's protocol ID
- 02082016
- Status last verified
- Oct 2018
- First submitted
- 2 Aug 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nasal Intermittent Positive Airway Pressure and Nasal Bi-level Positive Airway Pressure Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
- ClinicalTrials.gov ID
- NCT02901652
- Acronym / sponsor ID
- 02082016
- Conditions
- Prematurity, Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 15 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 is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Detailed description
Purpose is to compare introduction of NIPPV and nBiPAP in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Method
Primary Outcome Measures:
In NIPPV and BIPAP groups, comparison of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life
Secondary Outcome Measures:
- Compare patients' need of total duration of invasive and non-invasive respiratory support and the duration of free oxygen
- Compare oxygen need in postnatal day 28 and week 36
- Compare the presence and severity of BPD (Bronchopulmonary dysplasia)
- Compare premature morbidities such as PDA (patent ductus arteriosus), IVH (intraventricular haemorrhage), NEC (necrotizing enterocolitis), ROP (retinopathy of prematurity)
- Compare feeding intolerance, reaching birth weight and transition to full oral feeding time, hospitalization period
- Compare their neurodevelopment in postnatal age 2
Study Design In NIPPV group; non-synchronous mode will be used, and they will be titrated between FiO2: 021-0.50 in a respiratory rate of 20-40 / min, peak inspiratory pressure (PIP): 15-20 end-expiratory pressure (PEEP):5-6 cm H2O and target oxygen saturation: 90-95 %. In nBiPAP group; they will be titrated between 021-0.50, in non-synchronized PEEP:6 H2O, pressure amplitude: 3 cm H2O, FiO2 target oxygen saturation of 90-95 %.
Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.
Non-invasive respiratory support failure is set as follows:
- FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
- Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
- Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
- Severe respiratory distress,
- Pulmonary haemorrhage and cardiopulmonary arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIPPV | Active comparator | Device: noninvasive respiratory support devicesnoninvasive respiratory support devices This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment. |
| BİPAP | Active comparator | Device: noninvasive respiratory support devicesnoninvasive respiratory support devices This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment. |
Who may qualify
- Ages
- 1 hour to 3 days
- 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 (4 listed)
- Major congenital anomalies
- Presence of cardiovascular instability
- Intubation at admission to the NICU
- 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 |
|---|---|---|
| noninvasive respiratory support devices | Device | BİPAP, NIPPV |
Primary outcome
surfactant requirement
Time frame: 72 HOURS
surfactant requirement within the first 72 hours of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
Related trials for Prematurity
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nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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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.
Suna Oğuz, MD study director
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive respiratory support devices in people with Prematurity and Respiratory Distress Syndrome, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 4 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 18 Jul 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Büyüktiryaki, MD (+905054525576, mbuyuktiryaki@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surfactant 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 18 Jul 2019.