HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP for Respiratory Distress Syndrome of Prematurity
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|ClinicalTrials.gov Identifier: NCT02570217|
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : October 7, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Newborn Respiratory Distress Syndrome||Device: HHHFNC Device: NCPAP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||316 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||July 2014|
The patients receive respiratory support by mean of Heated Humidified High Flow Nasal cannula
infants receive non-invasive respiratory support by mean of HHHFNC
Other Name: PRECISION FLOW (Vapotherm,Stevensville, USA)
Active Comparator: NCPAP
Patients receive respiratory support by Nasal Continuous Positive Airways Pressure(NCPAP)
infants receive non-invasive respiratory support by mean of NCPAP
- 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 ]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.
- overall duration of respiratory assistance [ Time Frame: up to 2 years from birth ]respiratory assistance includes both invasive and non invasive respiratory supports
- overall duration of oxygen requirement [ Time Frame: up to 2 years from birth ]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.
- overall duration of non invasive respiratory assistance [ Time Frame: up to 2 years from birth ]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".
- Surfactant treatment [ Time Frame: through study completion, an average of 1 year ]the overall number of doses of surfactant are considered
- full enteral feeding [ Time Frame: through study completion, an average of 1 year ]Number of days required to reach the " full enteral feeding" (defined by a fluids intake about 120 ml/kg/day by enteral administration)
- overall duration of hospitalisation [ Time Frame: up to 2 years from birth ]
- air-leak syndrome [ Time Frame: through study completion, an average of 1 year ]
- Intra ventricular Hemorrage [ Time Frame: through study completion, an average of 1 year ]
- Patent Doctus Arterious [ Time Frame: through study completion, an average of 1 year ]If a pharmaceutical or surgical treatment is required is considered. Small doctuses closing spontaneously during the first days of life are not included.
- Infections [ Time Frame: through study completion, an average of 1 year ]Sepsis, pneumonia, cellulites and other infections are considered
- Necrotising Enterocolites (NEC) [ Time Frame: through study completion, an average of 1 year ]
- Bronchopulmonary Dysplasia [ Time Frame: up to 2 years from birth ]Jobe-Bancalari classification criteria are applied.
- Retinopathy of Prematurity [ Time Frame: through study completion, an average of 1 year ]
- overall mortality [ Time Frame: through study completion, an average of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570217
|NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy|
|Milan, Italy, 20122|
|Study Director:||Mariarosa Colnaghi, MD||IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy|