Respiratory Distress Syndrome In Premature InfantsNCT02396693
Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms
A study testing NIPPV, Bubble NCPAP and Ventilator NCPAP in people with Respiratory Distress Syndrome In Premature Infants, run by Federal University of Minas Gerais.
Trial summary
Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome in an attempt to assist failure extubation. The investigators investigated failure extubation in infants gestational age less than or equal to 34 weeks and weights less than or equal to 1500 grams. Read more about this study
- Who is it for?
- Ages 26 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome In Premature Infants
- What is being tested?
- NIPPV, Bubble NCPAP and Ventilator NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Nov 2013
- 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 26 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Were eligible for the study
- Newborn (NB) ≤ 34 weeks and 500g to the weight of ≤ 1500 grams with a diagnosis of respiratory distress syndrome (RDS) who had their first elective extubation.
Who cannot join
- Excluded patients with cardiorespiratory system malformations
- Genetic disorders
- Neuromuscular disease and malformations of the central nervous system.
About this study
Official title: Successful Extubation and Noninvasive Ventilation in Preterm Infants ≤ 1500g Terms
Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome in an attempt to assist failure extubation. The investigators investigated failure extubation in infants gestational age less than or equal to 34 weeks and weights less than or equal to 1500 grams. Neonates were randomized to noninvasive modalities support. 101 newborns were included in this study in three groups , group 1: Nasal Intermittent Positive Pressure Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure Bubble (NCPAP bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble Ventilator (NCPAP ventilator) (n=32)
Read the detailed description
The infants were randomly allocated after extubation used a list of computer-generated randomization in NIPPV modes (with the following settings: positive inspiratory pressure (PIP) < 16 centimeters of water (cm H2O), positive end-expiratory pressure (PEEP) 4-5 centimeters of water (cm H2O, backup respiratory rate (RR) < 18 cycles per minute flow 6-7 liters per minute (L / min) and inspiratory time (TI) according to the time constant for idae (0.30 to 0.34 seconds), and respirator seal to NCPAP water tower was adjusted to 4-5 centimeters of water (cm H2O) PEEP, flow 6-7 liters per minute (L / Min.) oxygen for both was adjusted to maintain arterial oxygen saturation between 85-95%
The criteria for extubation were defined using a protocol by the clinic staff, confirmed by arterial blood gases and chest X-ray, as well as adjustments of the ventilator settings.
Vital signs, blood gas parameters and noninvasive brackets were recorded before, immediately, 15, 30, 45 minutes, 1(hour) h, 2h, 12h, 24h and 48 h after extubation were documented.
Neonatal morbidities were documented until discharge, among these are: patent ductus arterious, necrotizing enterocolitis, retinopathy of prematurity, intracranial hemorrhage and pneumothorax.
Data on achievement of prenatal, antenatal steroids and surfactant administration were documented. All newborns were natural porcine surfactant Curosurf®.
The total duration of mechanical ventilation and oxygen were documented from birth until discharge or death. The supplemental oxygen or mechanical ventilation days was defined as daily requirement of fraction of inspired oxygen (FiO 2)> 0.21 or ventilation > 12 hours, respectively.
The newborns were followed for all interaction until discharge (about 5 weeks).
- Being tested
- NIPPV, Bubble NCPAP, Ventilator NCPAP
- Keywords
- Newborn, non invasive ventilation
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPPVDevice
Also called Non invasive ventilation
Ventilation with nasal intermittent positive pressure - Newborns randomized to this group underwent NIPPV, the respirators in TIME mode, set with the following settings : 5-6 centimeters of water (cmH2O) pressure positive end expiratory (PEEP); Flow rate of 6-8 liters per minute (L / min); PIP(positive inspiratory pressure) < 15 centimeters of water (cm H2O) ; respiratory frequency backup (FR) < 16 bpm; inspiratory time (IT) - 0.30 to 0.33 seconds (adjustable time constant according to the weight and baseline disease)
Bubble NCPAPDevice
Bubble NCPAP - Newborns randomized to this group bubble NCPAP, adjusted with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min), provided through oxygen sources and compressed air (15 liters per minute - L / min), which passes through a heated humidifier through a breathing circuit that goes to the newborn, and from him, for a plastic container (250 milliliters (ml) capacity and 14 centimeters) containing sterile distilled water, which is the bubble.
Ventilator NCPAPDevice
Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, of respirators in TIME mode set with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min).
| Study group | Role | What they receive |
|---|---|---|
| NIPPV | Experimental | NIPPV - Newborns randomized to this group underwent NIPPV, in noninvasive ventilation support intermittent, in TIME mode of the respirator. Receives: Device: NIPPV |
| Bubble NCPAP | Placebo comparator | Bubble NCPAP - Newborns randomized to this group bubble NCPAP, in noninvasive ventilation continuous, in bubble NCPAP. Receives: Device: Bubble NCPAP |
| Ventilator NCPAP | Placebo comparator | Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, in noninvasive ventilation continuous, in NCPAP mode of the respirator. Receives: Device: Ventilator NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of the extubation
The success rate of the extubation and Need for intubation within the first 48 hours after extubation in the three groups
Measured: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
Secondary outcomes (4)
Correlations of the noninvasive support (correlations with sex, gestational age (IG), total duration of oxygen use, full-time use of mechanical ventilation and bronchopulmonary dysplasia (DBP)
Related to noninvasive support and correlations with sex, gestational age (IG), total duration of oxygen use, full-time use of mechanical ventilation and bronchopulmonary dysplasia (DBP).
Measured: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
The failure and success of the noninvasive support (days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
The failure vs. success, with the days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
Measured: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
Incidence of the diseases during the hospitalization
Incidence of pneumothorax, patent ductus arterious (PDA), retinopathy of prematurity (HOP), peri-intraventricular hemorrhage (HPIV), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), nasal injury
Measured: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
Outcomes at discharge in days (Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration)
Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration
Measured: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome In Premature InfantsStudies 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Nascimento Santos Ribeiro, Federal University of Minas Gerais
- Investigators
- Cíntia Johnston, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396693
- Sponsor's protocol ID
- FUMinasGerais
- Status last verified
- Feb 2016
- First submitted
- 28 Jan 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jasani B, Nanavati R, Kabra N, Rajdeo S, Bhandari V. Comparison of non-synchronized nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure as post-extubation respiratory support in preterm infants with respiratory distress syndrome: a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(10):1546-51. doi: 10.3109/14767058.2015.1059809. Epub 2015 Jul 28.
PubMed 26135774Mehta P, Berger J, Bucholz E, Bhandari V. Factors affecting nasal intermittent positive pressure ventilation failure and impact on bronchopulmonary dysplasia in neonates. J Perinatol. 2014 Oct;34(10):754-60. doi: 10.1038/jp.2014.100. Epub 2014 May 29.
PubMed 24875408Bhandari V. Noninvasive respiratory support in the preterm infant. Clin Perinatol. 2012 Sep;39(3):497-511. doi: 10.1016/j.clp.2012.06.008.
PubMed 22954265Meneses J, Bhandari V, Alves JG. Nasal intermittent positive-pressure ventilation vs nasal continuous positive airway pressure for preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Pediatr Adolesc Med. 2012 Apr;166(4):372-6. doi: 10.1001/archpediatrics.2011.1142.
PubMed 22474063Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.
PubMed 23944299Khorana M, Paradeevisut H, Sangtawesin V, Kanjanapatanakul W, Chotigeat U, Ayutthaya JK. A randomized trial of non-synchronized Nasopharyngeal Intermittent Mandatory Ventilation (nsNIMV) vs. Nasal Continuous Positive Airway Pressure (NCPAP) in the prevention of extubation failure in pre-term < 1,500 grams. J Med Assoc Thai. 2008 Oct;91 Suppl 3:S136-42.
PubMed 19253509Bahman-Bijari B, Malekiyan A, Niknafs P, Baneshi MR. Bubble-CPAP vs. Ventilatory-CPAP in Preterm Infants with Respiratory Distress. Iran J Pediatr. 2011 Jun;21(2):151-8.
PubMed 23056781Kumar M, Avasthi S, Ahuja S, Malik GK, Singh SN. Unsynchronized Nasal Intermittent Positive Pressure Ventilation to prevent extubation failure in neonates: a randomized controlled trial. Indian J Pediatr. 2011 Jul;78(7):801-6. doi: 10.1007/s12098-010-0357-x. Epub 2011 Feb 2.
PubMed 21287368
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Extubation and Noninvasive Ventilation in Preterm Infants ≤ 1500g Terms
- ClinicalTrials.gov ID
- NCT02396693
- Acronym / sponsor ID
- FUMinasGerais
- Keywords
- Newborn, non invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Mar 2015 (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.
Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome in an attempt to assist failure extubation. The investigators investigated failure extubation in infants gestational age less than or equal to 34 weeks and weights less than or equal to 1500 grams. Neonates were randomized to noninvasive modalities support. 101 newborns were included in this study in three groups , group 1: Nasal Intermittent Positive Pressure Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure Bubble (NCPAP bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble Ventilator (NCPAP ventilator) (n=32)
Detailed description
The infants were randomly allocated after extubation used a list of computer-generated randomization in NIPPV modes (with the following settings: positive inspiratory pressure (PIP) < 16 centimeters of water (cm H2O), positive end-expiratory pressure (PEEP) 4-5 centimeters of water (cm H2O, backup respiratory rate (RR) < 18 cycles per minute flow 6-7 liters per minute (L / min) and inspiratory time (TI) according to the time constant for idae (0.30 to 0.34 seconds), and respirator seal to NCPAP water tower was adjusted to 4-5 centimeters of water (cm H2O) PEEP, flow 6-7 liters per minute (L / Min.) oxygen for both was adjusted to maintain arterial oxygen saturation between 85-95%
The criteria for extubation were defined using a protocol by the clinic staff, confirmed by arterial blood gases and chest X-ray, as well as adjustments of the ventilator settings.
Vital signs, blood gas parameters and noninvasive brackets were recorded before, immediately, 15, 30, 45 minutes, 1(hour) h, 2h, 12h, 24h and 48 h after extubation were documented.
Neonatal morbidities were documented until discharge, among these are: patent ductus arterious, necrotizing enterocolitis, retinopathy of prematurity, intracranial hemorrhage and pneumothorax.
Data on achievement of prenatal, antenatal steroids and surfactant administration were documented. All newborns were natural porcine surfactant Curosurf®.
The total duration of mechanical ventilation and oxygen were documented from birth until discharge or death. The supplemental oxygen or mechanical ventilation days was defined as daily requirement of fraction of inspired oxygen (FiO 2)> 0.21 or ventilation > 12 hours, respectively.
The newborns were followed for all interaction until discharge (about 5 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NIPPV | Experimental | Device: NIPPVNIPPV - Newborns randomized to this group underwent NIPPV, in noninvasive ventilation support intermittent, in TIME mode of the respirator. |
| Bubble NCPAP | Placebo comparator | Device: Bubble NCPAPBubble NCPAP - Newborns randomized to this group bubble NCPAP, in noninvasive ventilation continuous, in bubble NCPAP. |
| Ventilator NCPAP | Placebo comparator | Device: Ventilator NCPAPVentilator NCPAP - Newborns randomized to this group ventilator NCPAP, in noninvasive ventilation continuous, in NCPAP mode of the respirator. |
Who may qualify
- Ages
- 26 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Were eligible for the study
- Newborn (NB) ≤ 34 weeks and 500g to the weight of ≤ 1500 grams with a diagnosis of respiratory distress syndrome (RDS) who had their first elective extubation.
Key exclusion criteria (3 listed)
- Excluded patients with cardiorespiratory system malformations
- Genetic disorders
- Neuromuscular disease and malformations of the central nervous system.
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 |
|---|---|---|
| NIPPVAlso: Non invasive ventilationVentilation with nasal intermittent positive pressure - Newborns randomized to this group underwent NIPPV, the respirators in TIME mode, set with the following settings : 5-6 centimeters of water (cmH2O) pressure positive end expiratory (PEEP); Flow rate of 6-8 liters per minute (L / min); PIP(positive inspiratory pressure) < 15 centimeters of water (cm H2O) ; respiratory frequency backup (FR) < 16 bpm; inspiratory time (IT) - 0.30 to 0.33 seconds (adjustable time constant according to the weight and baseline disease) | Device | NIPPV |
| Bubble NCPAPBubble NCPAP - Newborns randomized to this group bubble NCPAP, adjusted with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min), provided through oxygen sources and compressed air (15 liters per minute - L / min), which passes through a heated humidifier through a breathing circuit that goes to the newborn, and from him, for a plastic container (250 milliliters (ml) capacity and 14 centimeters) containing sterile distilled water, which is the bubble. | Device | Bubble NCPAP |
| Ventilator NCPAPVentilator NCPAP - Newborns randomized to this group ventilator NCPAP, of respirators in TIME mode set with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min). | Device | Ventilator NCPAP |
Primary outcome
The success rate of the extubation
Time frame: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
The success rate of the extubation and Need for intubation within the first 48 hours after extubation in the three groups
4 secondary outcomes
Correlations of the noninvasive support (correlations with sex, gestational age (IG), total duration of oxygen use, full-time use of mechanical ventilation and bronchopulmonary dysplasia (DBP)
Time frame: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
The failure and success of the noninvasive support (days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
Time frame: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
Incidence of the diseases during the hospitalization
Time frame: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
Outcomes at discharge in days (Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration)
Time frame: Finished The newborns were followed for all interaction until discharge (about 5 weeks).
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 3 Feb 2016.
- Results publication: PubMed 26135774Jasani B, Nanavati R, Kabra N, Rajdeo S, Bhandari V. Comparison of non-synchronized nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure as post-extubation respiratory support in preterm infants with respiratory distress syndrome: a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(10):1546-51. doi: 10.3109/14767058.2015.1059809. Epub 2015 Jul 28.
- Results publication: PubMed 24875408Mehta P, Berger J, Bucholz E, Bhandari V. Factors affecting nasal intermittent positive pressure ventilation failure and impact on bronchopulmonary dysplasia in neonates. J Perinatol. 2014 Oct;34(10):754-60. doi: 10.1038/jp.2014.100. Epub 2014 May 29.
- Results publication: PubMed 22954265Bhandari V. Noninvasive respiratory support in the preterm infant. Clin Perinatol. 2012 Sep;39(3):497-511. doi: 10.1016/j.clp.2012.06.008.
- Results publication: PubMed 22474063Meneses J, Bhandari V, Alves JG. Nasal intermittent positive-pressure ventilation vs nasal continuous positive airway pressure for preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Pediatr Adolesc Med. 2012 Apr;166(4):372-6. doi: 10.1001/archpediatrics.2011.1142.
- Results publication: PubMed 23944299Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.
- Results publication: PubMed 19253509Khorana M, Paradeevisut H, Sangtawesin V, Kanjanapatanakul W, Chotigeat U, Ayutthaya JK. A randomized trial of non-synchronized Nasopharyngeal Intermittent Mandatory Ventilation (nsNIMV) vs. Nasal Continuous Positive Airway Pressure (NCPAP) in the prevention of extubation failure in pre-term < 1,500 grams. J Med Assoc Thai. 2008 Oct;91 Suppl 3:S136-42.
- Results publication: PubMed 23056781Bahman-Bijari B, Malekiyan A, Niknafs P, Baneshi MR. Bubble-CPAP vs. Ventilatory-CPAP in Preterm Infants with Respiratory Distress. Iran J Pediatr. 2011 Jun;21(2):151-8.
- Results publication: PubMed 21287368Kumar M, Avasthi S, Ahuja S, Malik GK, Singh SN. Unsynchronized Nasal Intermittent Positive Pressure Ventilation to prevent extubation failure in neonates: a randomized controlled trial. Indian J Pediatr. 2011 Jul;78(7):801-6. doi: 10.1007/s12098-010-0357-x. Epub 2011 Feb 2.
- 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.
Cíntia Johnston study chair
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing NIPPV, Bubble NCPAP and Ventilator NCPAP in people with Respiratory Distress Syndrome In Premature Infants, run by Federal University of Minas Gerais.
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 2 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 3 Feb 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.
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?
The success rate of the extubation (time frame: Finished The newborns were followed for all interaction until discharge (about 5 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396693, which also lists 8 linked publications.
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 3 Feb 2016.