NCT02570217

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

October 3, 2015

Last Update Submit

October 6, 2015

Conditions

Newborn Respiratory Distress Syndrome

Keywords

NCPAP, High Flow Nasal Cannula, pretem infants, NICU

Outcome Measures

Primary Outcomes (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.

    within 72 hrs from the beginning of the study mode

Secondary Outcomes (14)

  • overall duration of respiratory assistance

    up to 2 years from birth

  • overall duration of oxygen requirement

    up to 2 years from birth

  • overall duration of non invasive respiratory assistance

    up to 2 years from birth

  • Surfactant treatment

    through study completion, an average of 1 year

  • full enteral feeding

    through study completion, an average of 1 year

  • +9 more secondary outcomes

Study Arms (2)

HHHFNC

EXPERIMENTAL

The patients receive respiratory support by mean of Heated Humidified High Flow Nasal cannula

Device: HHHFNC

NCPAP

ACTIVE COMPARATOR

Patients receive respiratory support by Nasal Continuous Positive Airways Pressure(NCPAP)

Device: NCPAP

Interventions

HHHFNCDEVICE

infants receive non-invasive respiratory support by mean of HHHFNC

Also known as: PRECISION FLOW (Vapotherm,Stevensville, USA)
HHHFNC
NCPAPDEVICE

infants receive non-invasive respiratory support by mean of NCPAP

Also known as: Infant Flow Driver System (EME Ltd, Brighton, Sussex, UK), SiPAP (Viasys Healthcare, Palm Springs, CA)
NCPAP

Eligibility Criteria

Age29 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn
  • Parental Consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Milan, 20122, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27532363DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Mariarosa Colnaghi, MD

    IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 3, 2015

First Posted

October 7, 2015

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

IT(1)