Respirtory DistressNCT02421328
Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants
A study testing CPAP first (Fisher & Paykel Healthcare) and HHHFNC first (Fisher & Paykel Healthcare) in people with Respirtory Distress, run by Mansoura University Children Hospital at 2 sites in Egypt.
Trial summary
This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Respirtory Distress
- What is being tested?
- CPAP first (Fisher & Paykel Healthcare) and HHHFNC first (Fisher & Paykel Healthcare)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- May 2015to Oct 2016
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants < 37 weeks.
- Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
- On less than 35% oxygen.
Who cannot join
- Congenital and acquired problems of the gastrointestinal tract as necrotizing enterocolitis, esophageal perforation and tracheoesophageal fistula.
- Phrenic nerve injury and/or diaphragm paralysis
- Congenital/acquired neurological deficit and/or seizures
- Hemodynamic instability
- Congenital heart disease (including symptomatic patent ductus arteriosus)
- Undergoing treatment for sepsis or pneumonia.
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- Use of muscle relaxants, narcotic analgesics, or gastric motility agents.
- Congenital anomalies of respiratory tract.
- Infants requiring more than 35% oxygen.
- Infants with facial anomalies.
- Infants with pneumothorax and/or pneumomediatinum.
- Infants in the immediate postoperative period.
- Infants with significant gastric residues and vomiting.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Neonatal Intensive Care Unit, Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate, 35516
NICU, Mansoura University Children's Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Comparative Study of the Effects of Continuous Positive Airway Pressure and Heated, Humidified High Flow Nasal Cannula on Diaphragmatic Dimensions in Preterm Infants
This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants.
Read the detailed description
Preterm infants will be recruited consecutively from NICU of Mansoura University Children's Hospital. They will be randomized in two groups; one group will start on nasal CPAP (Fisher \& Paykel Healthcare, Auckland, New Z ealand) (Pressure 5 cmH2O) for 60 minutes and then will be switched to HHHFNC (Fisher \& Paykel Healthcare, Auckland, New Z ealand) (flow of 4 l/m) for another 60 minutes. The other group will start on HHHFNC and then switched to nasal CPAP.
After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be analyzed in different respiratory cycles and the average of 3 cycles will be calculated at the end of the 60 minutes periods on nasal CPAP and HHHFNC.
- Conditions
- Respirtory Distress
- Being tested
- CPAP first (Fisher & Paykel Healthcare), HHHFNC first (Fisher & Paykel Healthcare)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP first (Fisher & Paykel Healthcare)Device
Infants will start on nasal CPAP for 60 minutes and then switched to HHHFNC for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
HHHFNC first (Fisher & Paykel Healthcare)Device
Infants will start on HHHFNC for 60 minutes and then switched to nasal CPAP for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
| Study group | Role | What they receive |
|---|---|---|
| CPAP first | Active comparator | Infant will be given nasal CPAP for 60 minutes and then put on HHHFNC for another 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on nasal CPAP and HHHFNC. After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team Receives: Device: CPAP first (Fisher & Paykel Healthcare) |
| HHHFNC first | Active comparator | Infant will be given HHHFNC for 60 minutes and then switched to nasal CPAP for another 30 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on HHHFNC and nasal CPAP. After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team Receives: Device: HHHFNC first (Fisher & Paykel Healthcare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on nasal CPAP. Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections. All measurements will be performed during quiet breathing. Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Measured: at the end of each 60 minutes epoch on nasal CPAP
Right and left diaphragmatic excursion
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on nasal CPAP. The displacements of the liver and spleen will be monitored in real-time. Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration. The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion). Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Measured: at the end of each 60 minute epoch on CPAP
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on HHHFNC. Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections. All measurements will be performed during quiet breathing. Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Measured: at the end of each 60 minutes epochs on HHHNC
Right and left diaphragmatic excursion
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on HHHFNC. The displacements of the liver and spleen will be monitored in real-time. Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration. The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion). Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Measured: at the end of each 60 minutes epochs on HHHNC
Secondary outcomes (4)
Respiratory rate
Respiratory rate will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
Measured: At the end of each 60 minutes epochs on CPAP and HHHFNC
Heart rate
Heart rate will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
Measured: At the end of each 60 minutes epochs on CPAP and HHHFNC
Spo2
Oxygen saturation by pulse oximetry (SpO2) will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
Measured: At the end of each 60 minutes epochs on CPAP and HHHFNC
Number of apneas
Number of apneas will be recorded during the 60 minutes epoch on CPAP or HHHFNC
Measured: during the 60 minutes epochs on CPAP and HHHFNC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionOct 2016
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 Respirtory DistressStudies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Abdel-Hady, Mansoura University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421328
- Sponsor's protocol ID
- MS 874
- Status last verified
- Mar 2017
- First submitted
- 13 Apr 2015
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Mogy M, El-Halaby H, Attia G, Abdel-Hady H. Comparative Study of the Effects of Continuous Positive Airway Pressure and Nasal High-Flow Therapy on Diaphragmatic Dimensions in Preterm Infants. Am J Perinatol. 2018 Apr;35(5):448-454. doi: 10.1055/s-0037-1608682. Epub 2017 Nov 13.
PubMed 29132179
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Effects of Continuous Positive Airway Pressure and Heated, Humidified High Flow Nasal Cannula on Diaphragmatic Dimensions in Preterm Infants
- ClinicalTrials.gov ID
- NCT02421328
- Acronym / sponsor ID
- MS 874
- Conditions
- Respirtory Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Apr 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.
This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants.
Detailed description
Preterm infants will be recruited consecutively from NICU of Mansoura University Children's Hospital. They will be randomized in two groups; one group will start on nasal CPAP (Fisher \& Paykel Healthcare, Auckland, New Z ealand) (Pressure 5 cmH2O) for 60 minutes and then will be switched to HHHFNC (Fisher \& Paykel Healthcare, Auckland, New Z ealand) (flow of 4 l/m) for another 60 minutes. The other group will start on HHHFNC and then switched to nasal CPAP.
After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be analyzed in different respiratory cycles and the average of 3 cycles will be calculated at the end of the 60 minutes periods on nasal CPAP and HHHFNC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP first | Active comparator | Device: CPAP first (Fisher & Paykel Healthcare)Infant will be given nasal CPAP for 60 minutes and then put on HHHFNC for another 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on nasal CPAP and HHHFNC. After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team |
| HHHFNC first | Active comparator | Device: HHHFNC first (Fisher & Paykel Healthcare)Infant will be given HHHFNC for 60 minutes and then switched to nasal CPAP for another 30 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on HHHFNC and nasal CPAP. After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants < 37 weeks.
- Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
- On less than 35% oxygen.
Key exclusion criteria (13 listed)
- Congenital and acquired problems of the gastrointestinal tract as necrotizing enterocolitis, esophageal perforation and tracheoesophageal fistula.
- Phrenic nerve injury and/or diaphragm paralysis
- Congenital/acquired neurological deficit and/or seizures
- Hemodynamic instability
- Congenital heart disease (including symptomatic patent ductus arteriosus)
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 |
|---|---|---|
| CPAP first (Fisher & Paykel Healthcare)Infants will start on nasal CPAP for 60 minutes and then switched to HHHFNC for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs. | Device | CPAP first |
| HHHFNC first (Fisher & Paykel Healthcare)Infants will start on HHHFNC for 60 minutes and then switched to nasal CPAP for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs. | Device | HHHFNC first |
Primary outcome
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
Time frame: at the end of each 60 minutes epoch on nasal CPAP
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on nasal CPAP. Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections. All measurements will be performed during quiet breathing. Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Right and left diaphragmatic excursion
Time frame: at the end of each 60 minute epoch on CPAP
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on nasal CPAP. The displacements of the liver and spleen will be monitored in real-time. Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration. The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion). Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
Time frame: at the end of each 60 minutes epochs on HHHNC
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on HHHFNC. Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections. All measurements will be performed during quiet breathing. Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Right and left diaphragmatic excursion
Time frame: at the end of each 60 minutes epochs on HHHNC
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on HHHFNC. The displacements of the liver and spleen will be monitored in real-time. Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration. The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion). Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
4 secondary outcomes
Respiratory rate
Time frame: At the end of each 60 minutes epochs on CPAP and HHHFNC
Heart rate
Time frame: At the end of each 60 minutes epochs on CPAP and HHHFNC
Spo2
Time frame: At the end of each 60 minutes epochs on CPAP and HHHFNC
Number of apneas
Time frame: during the 60 minutes epochs on CPAP and HHHFNC
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 13 Mar 2017.
- Derived from this study: PubMed 29132179El-Mogy M, El-Halaby H, Attia G, Abdel-Hady H. Comparative Study of the Effects of Continuous Positive Airway Pressure and Nasal High-Flow Therapy on Diaphragmatic Dimensions in Preterm Infants. Am J Perinatol. 2018 Apr;35(5):448-454. doi: 10.1055/s-0037-1608682. Epub 2017 Nov 13.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP first (Fisher & Paykel Healthcare) and HHHFNC first (Fisher & Paykel Healthcare) in people with Respirtory Distress, run by Mansoura University Children Hospital at 2 sites in Egypt.
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 3 inclusion and 13 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness) (time frame: at the end of each 60 minutes epoch on nasal CPAP). The study lists 4 primary outcomes in all. 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 NCT02421328, 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 13 Mar 2017.