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

Newborn Respiratory Distress Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570217
• Other study ID #: HHHFNC vs NCPAP 2012
• Secondary ID: IRCCSMaggioreH
• Status: Completed
• Phase: N/A
• First received: October 3, 2015
• Last updated: October 6, 2015
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

• Inborn

• Parental Consent

Exclusion Criteria:

• No parental consent

• Major congenital malformations

• Severe intra ventricular hemorrage diagnosed early after birth

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Newborn Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• HHHFNC
infants receive non-invasive respiratory support by mean of HHHFNC
• NCPAP
infants receive non-invasive respiratory support by mean of NCPAP

Locations

Country	Name	City	State
Italy	NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy	Milan

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Dr Anna Lavizzari, Dr Francesca Gaia Ciuffini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 72 hrs from the beginning of the study mode	No
Secondary	overall duration of respiratory assistance	respiratory assistance includes both invasive and non invasive respiratory supports	up to 2 years from birth	No
Secondary	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.	up to 2 years from birth	No
Secondary	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".	up to 2 years from birth	No
Secondary	Surfactant treatment	the overall number of doses of surfactant are considered	through study completion, an average of 1 year	Yes
Secondary	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)	through study completion, an average of 1 year	No
Secondary	overall duration of hospitalisation		up to 2 years from birth	No
Secondary	air-leak syndrome		through study completion, an average of 1 year	Yes
Secondary	Intra ventricular Hemorrage		through study completion, an average of 1 year	Yes
Secondary	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.	through study completion, an average of 1 year	Yes
Secondary	Infections	Sepsis, pneumonia, cellulites and other infections are considered	through study completion, an average of 1 year	Yes
Secondary	Necrotising Enterocolites (NEC)		through study completion, an average of 1 year	Yes
Secondary	Bronchopulmonary Dysplasia	Jobe-Bancalari classification criteria are applied.	up to 2 years from birth	Yes
Secondary	Retinopathy of Prematurity		through study completion, an average of 1 year	Yes
Secondary	overall mortality		through study completion, an average of 1 year	Yes