Prematurity, Mechanical VentilationNCT02681315

Comparison of Two Flow Rates of HHHFNC to Prevent Extubation Failure in Preterm Infants

A study testing HHHFNC 6 liter minute and HHHFNC 3 liters/min in people with Prematurity, Mechanical Ventilation, run by Mansoura University Children Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6 liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates of extubation failure in mechanically ventilated preterm infants. Read more about this study

Who is it for?: Ages 1 hour to 30 days
Conditions the study is for: Prematurity, Mechanical Ventilation
What is being tested?: HHHFNC 6 liter minute and HHHFNC 3 liters/min
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteEgypt
Study dates: Mar 2016to Jan 2018
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 30 days
All sexes
No healthy volunteers
Child

Who may be able to join

Infants born at less than 37 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and are considered ready for extubation by the clinical team. Infants will be enrolled after written informed parental consent is obtained.

Who cannot join

Suspected upper airway obstruction, congenital airway malformations, or major cardiopulmonary malformations

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Neonatal Intensive Care Unit, Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate, 35516

Other trials in Egypt

About this study

Official title: HHHFNC to Prevent Extubation Failure in Preterm Infants: A Randomized Controlled Trial

Read the detailed description

HHHFNC has been proposed as an alternative to nasal continuous positive airway pressure (nCPAP) in neonatal intensive care units (NICUs) for preventing extubation failure. In a recent international survey on periextubation practices in extremely preterm infants, nCPAP was the most common type of respiratory support used (84%) followed by nasal intermittent positive pressure ventilation (55%) and HHHFNC (33%). Moreover, HHHFNC appears to have efficacy and safety similar to those of nCPAP when applied immediately post-extubation to prevent extubation failure in preterm infants. and resulted in significantly less nasal trauma in the first 7 days post-extubation than nCPAP. However, the best flow rates of HHHFNC to prevent extubation failure remains to be known.

This RCT aims to compare the efficacy and safety of postextubation respiratory support via HHHFNC at two different flow rates (6 L/min. versus 3 L/min) regarding successful extubation after a period of endotracheal positive pressure ventilation. We hypothesized that postextubation respiratory support via HHHFNC at a flow rate of 6 L/min. will result in a greater proportion of preterm infants being successfully extubated after a period of endotracheal positive pressure ventilation compared with HHHFNC at a flow rate of 3 L/min.

Conditions: Prematurity, Mechanical Ventilation
Being tested: HHHFNC 6 liter minute, HHHFNC 3 liters/min
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HHHFNC 6 liter minuteDevice
Infants allocated to HHHFNC at 6 L/min. will be extubated to a HHHFNC flow of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.
HHHFNC 3 liters/minDevice
Infants allocated to HHHFNC at 3 L/min. will be extubated to a HHHFNC flow of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.

Study groups in NCT02681315
Study group	Role	What they receive
6 liter/min group	Experimental	Infants will be extubated to a HHHFNC (Fisher and Paykel Healthcare , Auckland, New Zealand) at ﬂow rate of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation. Receives: Device: HHHFNC 6 liter minute
3 liter/min group	Active comparator	Infants will be extubated to HHHFNC (Fisher and Paykel Healthcare , Auckland, New Zealand) a ﬂow rate of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation. Receives: Device: HHHFNC 3 liters/min

What is being measured

The primary outcome is the main question the study is designed to answer.

Extubation failure
Extubation failure criteria will be defined as follows:
1. Apnea (respiratory pause >20 seconds), more than 6 episodes requiring physical stimulation in 6 hours or 1 requiring intermittent positive pressure ventilation.
2. Respiratory acidosis with pH <7.25 and Peripheral arterial oxygen saturation (PaCO2) >65 mmHg. ( >15% sustained increase in FiO2 from extubation. 4. Cardiovascular collapse (heart rate <60 beats per minute or shock. 5. Persistent marked/severe retractions. Extubation failure will be deemed to occur if any single criterion was met in any one of the 7 days after extubation. The decision to reintubate an infant and mechanical ventilation variables and subsequent extubation attempts after reintubation will be managed at the discretion of the clinical team.
Measured: the 7 days after extubation

Secondary outcomes (8)

Mortality
Death within the 96 hour post-extubation period or at any time after randomization.
Measured: within the 96 hour post-extubation period or at any time after with expected average of 5 weeks
Total duration of mechanical ventilation
Total duration of mechanical ventilation during NICU admission
Measured: During NICU admission with expected average of 5 weeks
Total duration of oxygen supplementation
Total duration of oxygen supplementation during NICU admission
Measured: During NICU admission with expected average of 5 weeks
Bronchopulmonary dysplasia (BPD)
BPD defined by oxygen requirement at 36 weeks' post-menstrual age.
Measured: at 36 weeks' post-menstrual age.
Severe BPD
Severe BPD defined as oxygen requirement with fraction of inspired oxygen (FiO2) >0.30 or need for positive pressure support at 36 weeks' post-menstrual age.
Measured: at 36 weeks' post-menstrual age.
The combined outcome variables of death before 36 weeks PMA or BPD
The combined outcome variables of death before 36 weeks PMA or BPD will be used to adjust for occurrence of death after extubation but before the time of assessment of BPD.
Measured: at 36 weeks' post-menstrual age.
The combined outcome variables of death before 36 weeks PMA or severe BPD
The combined outcome variables of death before 36 weeks' post-menstrual age (PMA) or severe BPD will be used to adjust for occurrence of death after extubation but before the time of assessment of BPD.
Measured: at 36 weeks' post-menstrual age
Other neonatal morbidities (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity)
The occurrence of neonatal morbidities occurring before, during the 96 hours post-extubation, and at any time thereafter will be documented (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity).
Measured: baseline, during the 96 hours post-extubation, and at any time thereafter during NICU stay with an expected average of 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jan 2018

First posted12 Feb 2016 (estimated)
Study startMar 2016
Primary completionJan 2018
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Prematurity, Mechanical VentilationStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02681315
Sponsor's protocol ID: MS/15.10.41
Status last verified: Sep 2017
First submitted: 10 Feb 2016
Last updated: 25 Feb 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Al-Mandari H, Shalish W, Dempsey E, Keszler M, Davis PG, Sant'Anna G. International survey on periextubation practices in extremely preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015 Sep;100(5):F428-31. doi: 10.1136/archdischild-2015-308549. Epub 2015 Jun 10.
PubMed 26063193
Collaborative Group for the Multicenter Study on Heated Humidified High-flow Nasal Cannula Ventilation. [Efficacy and safety of heated humidified high-flow nasal cannula for prevention of extubation failure in neonates]. Zhonghua Er Ke Za Zhi. 2014 Apr;52(4):271-6. Chinese.
PubMed 24915914
Collins CL, Holberton JR, Barfield C, Davis PG. A randomized controlled trial to compare heated humidified high-flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature infants. J Pediatr. 2013 May;162(5):949-54.e1. doi: 10.1016/j.jpeds.2012.11.016. Epub 2012 Dec 20.
PubMed 23260098
Collins CL, Barfield C, Horne RS, Davis PG. A comparison of nasal trauma in preterm infants extubated to either heated humidified high-flow nasal cannulae or nasal continuous positive airway pressure. Eur J Pediatr. 2014 Feb;173(2):181-6. doi: 10.1007/s00431-013-2139-8. Epub 2013 Aug 18.
PubMed 23955516

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
Not yet recruiting
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
Respiratory Distress Syndrome (RDS), Newborn
Not yet recruitingObservational study
Predictors of Prolonged Mechanical Ventilation in Preterm Infants
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All Prematurity, Mechanical Ventilation trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HHHFNC to Prevent Extubation Failure in Preterm Infants: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02681315
Acronym / sponsor ID: MS/15.10.41
Conditions: Prematurity, Mechanical Ventilation
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Mansoura University Children HospitalUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: Jan 2018 (actual)
Study completion: Jan 2018 (actual)
First posted: 12 Feb 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
6 liter/min group	Experimental	Device: HHHFNC 6 liter minuteInfants will be extubated to a HHHFNC (Fisher and Paykel Healthcare , Auckland, New Zealand) at ﬂow rate of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.
3 liter/min group	Active comparator	Device: HHHFNC 3 liters/minInfants will be extubated to HHHFNC (Fisher and Paykel Healthcare , Auckland, New Zealand) a ﬂow rate of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.

Who may qualify

Ages: 1 hour to 30 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Infants born at less than 37 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and are considered ready for extubation by the clinical team. Infants will be enrolled after written informed parental consent is obtained.

Key exclusion criteria (1 listed)

Suspected upper airway obstruction, congenital airway malformations, or major cardiopulmonary malformations

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
HHHFNC 6 liter minuteInfants allocated to HHHFNC at 6 L/min. will be extubated to a HHHFNC flow of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.	Device	6 liter/min group
HHHFNC 3 liters/minInfants allocated to HHHFNC at 3 L/min. will be extubated to a HHHFNC flow of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.	Device	3 liter/min group

Primary outcome

Extubation failure
Time frame: the 7 days after extubation
Extubation failure criteria will be defined as follows: 1. Apnea (respiratory pause >20 seconds), more than 6 episodes requiring physical stimulation in 6 hours or 1 requiring intermittent positive pressure ventilation. 2. Respiratory acidosis with pH <7.25 and Peripheral arterial oxygen saturation (PaCO2) >65 mmHg. ( >15% sustained increase in FiO2 from extubation. 4. Cardiovascular collapse (heart rate <60 beats per minute or shock. 5. Persistent marked/severe retractions. Extubation failure will be deemed to occur if any single criterion was met in any one of the 7 days after extubation. The decision to reintubate an infant and mechanical ventilation variables and subsequent extubation attempts after reintubation will be managed at the discretion of the clinical team.

8 secondary outcomes

Mortality
Time frame: within the 96 hour post-extubation period or at any time after with expected average of 5 weeks
Total duration of mechanical ventilation
Time frame: During NICU admission with expected average of 5 weeks
Total duration of oxygen supplementation
Time frame: During NICU admission with expected average of 5 weeks
Bronchopulmonary dysplasia (BPD)
Time frame: at 36 weeks' post-menstrual age.
Severe BPD
Time frame: at 36 weeks' post-menstrual age.
The combined outcome variables of death before 36 weeks PMA or BPD
Time frame: at 36 weeks' post-menstrual age.
The combined outcome variables of death before 36 weeks PMA or severe BPD
Time frame: at 36 weeks' post-menstrual age
Other neonatal morbidities (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity)
Time frame: baseline, during the 96 hours post-extubation, and at any time thereafter during NICU stay with an expected average of 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 25 Feb 2020.
Background: PubMed 26063193Al-Mandari H, Shalish W, Dempsey E, Keszler M, Davis PG, Sant'Anna G. International survey on periextubation practices in extremely preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015 Sep;100(5):F428-31. doi: 10.1136/archdischild-2015-308549. Epub 2015 Jun 10.
Background: PubMed 24915914Collaborative Group for the Multicenter Study on Heated Humidified High-flow Nasal Cannula Ventilation. [Efficacy and safety of heated humidified high-flow nasal cannula for prevention of extubation failure in neonates]. Zhonghua Er Ke Za Zhi. 2014 Apr;52(4):271-6. Chinese.
Background: PubMed 23260098Collins CL, Holberton JR, Barfield C, Davis PG. A randomized controlled trial to compare heated humidified high-flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature infants. J Pediatr. 2013 May;162(5):949-54.e1. doi: 10.1016/j.jpeds.2012.11.016. Epub 2012 Dec 20.
Background: PubMed 23955516Collins CL, Barfield C, Horne RS, Davis PG. A comparison of nasal trauma in preterm infants extubated to either heated humidified high-flow nasal cannulae or nasal continuous positive airway pressure. Eur J Pediatr. 2014 Feb;173(2):181-6. doi: 10.1007/s00431-013-2139-8. Epub 2013 Aug 18.
Individual participant dataSharing planned: No

Related trials for Prematurity, Mechanical Ventilation

Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
Not yet recruiting
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
Respiratory Distress Syndrome (RDS), Newborn
Not yet recruitingObservational study
Predictors of Prolonged Mechanical Ventilation in Preterm Infants
Premature Birth, Respiration Failure

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.

Hesham Abdel-Hady principal investigator

Mansoura University Children"s 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 HHHFNC 6 liter minute and HHHFNC 3 liters/min in people with Prematurity, Mechanical Ventilation, run by Mansoura University Children Hospital at 1 site 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 1 inclusion and 1 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 25 Feb 2020. 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 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?

Extubation failure (time frame: the 7 days after extubation). 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 NCT02681315, which also lists 4 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 25 Feb 2020.