Premature BirthNCT02014493
Changes in Respiratory Effort in Preterm Infants
A study testing High Flow Nasal Cannulae (HFNC) and Continuous Positive Airway Pressure (CPAP) in people with Premature Birth, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature respiratory center and having respiratory distress. CPAP requires intensive care monitoring and special qualified staff. Read more about this study
- Who is it for?
- Ages 28 to 34 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- High Flow Nasal Cannulae (HFNC) and Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Jun 2015
- 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 28 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants who are stable on Nasal Continuous Positive Airway Pressure (nCPAP) with flow 8l/min
- <34 and >28 gestational weeks, respiratory stable last 72 hours.
- 1 kilo
- Fi02< 30%
- C02<9
- written informed consent by parents/caregivers
Who cannot join
- need for sedation
- damage on the phrenic nerve
- anomalies in the upper airways
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Effort in Preterm Infants in the Transition From Continuous Positive Airway Pressure (CPAP) to High Flow Nasal Cannulae (HFNC)
Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature respiratory center and having respiratory distress. CPAP requires intensive care monitoring and special qualified staff. Continuous positive pressure makes a constant noise around the child and can lead to an uncomfortable environment.The fixture of the binasal prongs can cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered important for the child.
Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive care units.HFNC is considered to be easy to apply and a more comfortable respiratory support for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from intensive respiratory support, to prevent respiratory distress and as a respiratory support after extubation.
There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is to investigate the preterm infants respiratory effort by measuring electrical activity in diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a scoring system inspired by Silverman- Andersen retraction score. It is expected that measured electrical activity in the diaphragm, measured respiratory parameters combined with bedside observations provide applicable knowledge about preterm infants respiratory effort in transition from CPAP to HFNC.
Read the detailed description
Data material will be stored on a separate computer in a sheltered home Directory. All data will be anonymous. Edi signals are transported from Servo-I ventilator with neural access through a communication port to a personal computer.Respiratory parameters will be stored in Picis (High Performance Hospital Information System). For the Statistical analyzes a T-test will be carried out, and data from the pilot study will decide the power to see whether we reject or retain the 0 hypothesis: " There are no changes in the preterm infants respiratory effort in transition from CPAP to HFNC".
- Conditions
- Premature Birth
- Being tested
- High Flow Nasal Cannulae (HFNC), Continuous Positive Airway Pressure (CPAP)
- Keywords
- Respiration, Noninvasive Ventilation, Work of breathing, Infant, premature, Electromyography, Diaphragm
- Medical subject headings
- Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannulae (HFNC)Procedure or surgery
HFNC 6 l/pr.min
Continuous Positive Airway Pressure (CPAP)Procedure or surgery
CPAP 6 l/pr.min
| Study group | Role | What they receive |
|---|---|---|
| HFNC first | Active comparator | 4 hours with High Flow Nasal Cannulae (HFNC) 6 l/pr.min, then 4 hours with Continuous Positive Airway Pressure (CPAP) 6l/pr.min. Receives: Procedure: High Flow Nasal Cannulae (HFNC) |
| CPAP first | Active comparator | 4 hours Continuous Positive Airway Pressure (CPAP) 6 l/pr.min, then 4 hours High Flow Nasal Cannulae (HFNC) 6 l/pr.min. Receives: Procedure: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural control of respiration
reflected by electrical activity of the diaphragm (Edi): inspiratory drive (Edi peak) and tonic activity (Edi min). A nasogastric feeding tube with ten microsensors will measure action potentials from the phrenic nerve to the diaphragm.
Measured: 4 months
Secondary outcomes (1)
Respiratory signs
Observation scale inspired by Silverman- Anderson retraction score. Observation of chest movement, intercostal retraction and xiphoid retraction.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Håkon Bergseng, MD PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014493
- Sponsor's protocol ID
- HHB-2013
- Status last verified
- Mar 2018
- First submitted
- 4 Dec 2013
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Brenne H, Grunewaldt KH, Follestad T, Bergseng H. A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. Acta Paediatr. 2018 Oct;107(10):1726-1732. doi: 10.1111/apa.14303. Epub 2018 Apr 4.
PubMed 29504671
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Effort in Preterm Infants in the Transition From Continuous Positive Airway Pressure (CPAP) to High Flow Nasal Cannulae (HFNC)
- ClinicalTrials.gov ID
- NCT02014493
- Acronym / sponsor ID
- HHB-2013
- Conditions
- Premature Birth
- Keywords
- Respiration, Noninvasive Ventilation, Work of breathing, Infant, premature, Electromyography, Diaphragm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Dec 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.
Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature respiratory center and having respiratory distress. CPAP requires intensive care monitoring and special qualified staff. Continuous positive pressure makes a constant noise around the child and can lead to an uncomfortable environment.The fixture of the binasal prongs can cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered important for the child.
Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive care units.HFNC is considered to be easy to apply and a more comfortable respiratory support for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from intensive respiratory support, to prevent respiratory distress and as a respiratory support after extubation.
There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is to investigate the preterm infants respiratory effort by measuring electrical activity in diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a scoring system inspired by Silverman- Andersen retraction score. It is expected that measured electrical activity in the diaphragm, measured respiratory parameters combined with bedside observations provide applicable knowledge about preterm infants respiratory effort in transition from CPAP to HFNC.
Detailed description
Data material will be stored on a separate computer in a sheltered home Directory. All data will be anonymous. Edi signals are transported from Servo-I ventilator with neural access through a communication port to a personal computer.Respiratory parameters will be stored in Picis (High Performance Hospital Information System). For the Statistical analyzes a T-test will be carried out, and data from the pilot study will decide the power to see whether we reject or retain the 0 hypothesis: " There are no changes in the preterm infants respiratory effort in transition from CPAP to HFNC".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC first | Active comparator | Procedure: High Flow Nasal Cannulae (HFNC)4 hours with High Flow Nasal Cannulae (HFNC) 6 l/pr.min, then 4 hours with Continuous Positive Airway Pressure (CPAP) 6l/pr.min. |
| CPAP first | Active comparator | Procedure: Continuous Positive Airway Pressure (CPAP)4 hours Continuous Positive Airway Pressure (CPAP) 6 l/pr.min, then 4 hours High Flow Nasal Cannulae (HFNC) 6 l/pr.min. |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preterm infants who are stable on Nasal Continuous Positive Airway Pressure (nCPAP) with flow 8l/min
- <34 and >28 gestational weeks, respiratory stable last 72 hours.
- 1 kilo
- Fi02< 30%
- C02<9
Key exclusion criteria (3 listed)
- need for sedation
- damage on the phrenic nerve
- anomalies in the upper airways
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 |
|---|---|---|
| High Flow Nasal Cannulae (HFNC)HFNC 6 l/pr.min | Procedure or surgery | HFNC first |
| Continuous Positive Airway Pressure (CPAP)CPAP 6 l/pr.min | Procedure or surgery | CPAP first |
Primary outcome
Neural control of respiration
Time frame: 4 months
reflected by electrical activity of the diaphragm (Edi): inspiratory drive (Edi peak) and tonic activity (Edi min). A nasogastric feeding tube with ten microsensors will measure action potentials from the phrenic nerve to the diaphragm.
1 secondary outcome
Respiratory signs
Time frame: 4 months
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 8 Mar 2018.
- Results publication: PubMed 29504671Brenne H, Grunewaldt KH, Follestad T, Bergseng H. A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. Acta Paediatr. 2018 Oct;107(10):1726-1732. doi: 10.1111/apa.14303. Epub 2018 Apr 4.
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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.
Håkon Bergseng, MD PhD principal investigator
St. Olavs 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 High Flow Nasal Cannulae (HFNC) and Continuous Positive Airway Pressure (CPAP) in people with Premature Birth, run by St. Olavs Hospital at 1 site in Norway.
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 6 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 8 Mar 2018. 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 Norway. 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?
Neural control of respiration (time frame: 4 months). 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 NCT02014493, which also lists 1 linked publication.
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 8 Mar 2018.