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Newborn Respiratory Distress SyndromeNCT02570217

HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP for Respiratory Distress Syndrome of Prematurity

A study testing HHHFNC and NCPAP in people with Newborn Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

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

Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the following treatments as non invasive respiratory support if they develop mild to moderate Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2) HHHFNC providing a flow 4-6 l/min. Read more about this study

Who is it for?
Ages 29 to 36 weeks
Conditions the study is for
Newborn Respiratory Distress Syndrome
What is being tested?
HHHFNC and NCPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
1 siteItaly
Study dates
Jan 2012to Jul 2014
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 29 to 36 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Inborn
  • Parental Consent

Who cannot join

  • No parental consent
  • Major congenital malformations
  • Severe intra ventricular hemorrage diagnosed early after birth

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

    Milan, 20122

Other trials in Italy

About this study

Official title: HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP (Nasal Continuous Positive Airway Pressure) in Preterm Infants With Mild to Moderate Respiratory Distress Syndrome (RDS): a Randomized Clinical Trial.

Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the following treatments as non invasive respiratory support if they develop mild to moderate Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2) HHHFNC providing a flow 4-6 l/min.

The aim of the study is to assess efficacy and safety of relative "new" form of respiratory support (HHHFNC) versus a more common one (NCPAP).

Read the detailed description

Preterm infants are eligible to the study if they present mild to moderate Respiratory Distress Syndrome (RDS) defined by the following criteria: need of FiO2 ( Fraction of Inspired Oxygen) ≥0.30 to keep a target SpO2 (Periferal Oxygen Saturation) beetween 88-93% and/or Silverman score ≥5. To confirm the diagnosis a Chest XR is performed as routinarily in the ward before starting the respiratory support.

They are randomly assigned to one of the treatment groups cited in "brief summary" by means of closed envelops. A block randomization is applided with a blok size of 4. The randomization is stratified per groups accoring to gestational age: from 29+0 to 32+6; from 33+0 to 34+6; from 35+0 to 36+6 weeks+days.

Once the treatment is started, for the group NCPAP there is the possibility to switch to the mode "Bi-PAP" if: there are more than 4 episodes of apnoea per hour or more than 2 episodes requiring positive pressure ventilation or if deemed by clinicians for increased work of breathing assesed by the Silverman score.

For all the groups, if the FiO2 requirement is persistently higher than 0.35-0.40 per target SpO2 86-93% and/or dyspnoea defined by Silverman score > 6 after starting the respiratory support, newborns receive Surfactant by "INSURE" technique, involving endotracheal intubation by direct laryngoscopic vision, endotracheal administration of surfactant (Curosurf, Chiesi Pharmaceutics, Parma, Italy) 200 mg/kg and finally extubation.

After the administration of surfactant, if FiO2 requirement is persistently >0.4 to keep SpO2 86-93% or severe apnea episodes are present (apnea episodes > 4/hr or >2/hr requiring positive pressure ventilation) or at the blood gas (capillary or venous) PaCO2>70 mmHg and pH<7.20, newborns are intubated and mechanically ventilated.

For all the newborns enrolled in the study, capillary or venous blood gas is checked every 6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. Further controls follow the routine of the ward.

Weaning is started decreasing HHHFNC flow by 1 lpm or nCPAP pressure by 1 cmH2O pressure if infants are presenting FIO2 < 0.30 to target SpO2 and minimal or no signs of respiratory effort. The respiratory support is discontinued for flow ≤ 2 lpm or pressure ≤ 2 cmH2O.

Being tested
HHHFNC, NCPAP
Keywords
NCPAP, High Flow Nasal Cannula, pretem infants, NICU
Medical subject headings
Pulmonary Atelectasis

What participants receive

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

  • HHHFNCDevice

    Also called PRECISION FLOW (Vapotherm,Stevensville, USA)

    infants receive non-invasive respiratory support by mean of HHHFNC

  • NCPAPDevice

    Also called Infant Flow Driver System (EME Ltd, Brighton, Sussex, UK), SiPAP (Viasys Healthcare, Palm Springs, CA)

    infants receive non-invasive respiratory support by mean of NCPAP

Study groups in NCT02570217
Study groupRoleWhat they receive
HHHFNCExperimentalThe patients receive respiratory support by mean of Heated Humidified High Flow Nasal cannula
Receives: Device: HHHFNC
NCPAPActive comparatorPatients receive respiratory support by Nasal Continuous Positive Airways Pressure(NCPAP)
Receives: Device: NCPAP

What is being measured

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

  1. number of patients needing intubation and mechanical ventilation within 72 hrs from the beginning of the study mode

    The procedure defined as INSURE and described in details in the section "Detailed Study Description" is not considered as a failure for the primary outcome.

    Measured: within 72 hrs from the beginning of the study mode

Secondary outcomes (14)

  1. overall duration of respiratory assistance

    respiratory assistance includes both invasive and non invasive respiratory supports

    Measured: up to 2 years from birth

  2. overall duration of oxygen requirement

    Apart from invasive and non invasive respiratory supports, for this specific outcome are considered also the days of oxygen administration by devices other then ventilators or HHHFNC devices.

    Measured: up to 2 years from birth

  3. overall duration of non invasive respiratory assistance

    If later during the hospitalisation the newborn receive non invasive ventilation, even if for different reasons from the beginning and/or by mean of a different mode or device, this is registered and computed as "overall non invasive ventilation".

    Measured: up to 2 years from birth

  4. Surfactant treatment

    the overall number of doses of surfactant are considered

    Measured: through study completion, an average of 1 year

  5. full enteral feeding

    Number of days required to reach the " full enteral feeding" (defined by a fluids intake about 120 ml/kg/day by enteral administration)

    Measured: through study completion, an average of 1 year

  6. overall duration of hospitalisation

    Measured: up to 2 years from birth

  7. air-leak syndrome

    Measured: through study completion, an average of 1 year

  8. Intra ventricular Hemorrage

    Measured: through study completion, an average of 1 year

  9. Patent Doctus Arterious

    If a pharmaceutical or surgical treatment is required is considered. Small doctuses closing spontaneously during the first days of life are not included.

    Measured: through study completion, an average of 1 year

  10. Infections

    Sepsis, pneumonia, cellulites and other infections are considered

    Measured: through study completion, an average of 1 year

  11. Necrotising Enterocolites (NEC)

    Measured: through study completion, an average of 1 year

  12. Bronchopulmonary Dysplasia

    Jobe-Bancalari classification criteria are applied.

    Measured: up to 2 years from birth

  13. Retinopathy of Prematurity

    Measured: through study completion, an average of 1 year

  14. overall mortality

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted7 Oct 2015 (estimated)
  2. Study startJan 2012
  3. Primary completionJun 2014
  4. Study completionJul 2014

Resources

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
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02570217
Sponsor's protocol ID
HHHFNC vs NCPAP 2012
Other IDs
IRCCSMaggioreH
Status last verified
Oct 2015
First submitted
3 Oct 2015
Last updated
7 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Lavizzari A, Colnaghi M, Ciuffini F, Veneroni C, Musumeci S, Cortinovis I, Mosca F. Heated, Humidified High-Flow Nasal Cannula vs Nasal Continuous Positive Airway Pressure for Respiratory Distress Syndrome of Prematurity: A Randomized Clinical Noninferiority Trial. JAMA Pediatr. 2016 Aug 8. doi: 10.1001/jamapediatrics.2016.1243. Online ahead of print.

    PubMed 27532363

Questions about this trial

What is this clinical trial studying?

A study testing HHHFNC and NCPAP in people with Newborn Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

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 7 Oct 2015. 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 Italy. 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?

number of patients needing intubation and mechanical ventilation within 72 hrs from the beginning of the study mode (time frame: within 72 hrs from the beginning of the study mode). 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 NCT02570217, 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 7 Oct 2015.

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