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High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants (VAPORAM)

Primary Purpose

Preterm Infant

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vapotherm
NIPPV
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures.
  • Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation.
  • Signed parental informed consent by one of the parents

Exclusion Criteria:

  • Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities
  • Presence of a pneumothorax prior to enrollment
  • Hemodynamic instability due to sepsis or hemorrhage
  • Inability to obtain parental consent
  • Shortage of suitable equipment
  • Infants who were intubated solely for surgery

Sites / Locations

  • Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vapotherm arm

NIPPV arm

Arm Description

Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA

Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator

Outcomes

Primary Outcome Measures

Rate of intubation within 7 days of starting the study treatment
Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas

Secondary Outcome Measures

Full Information

First Posted
February 19, 2019
Last Updated
February 7, 2021
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03853161
Brief Title
High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants
Acronym
VAPORAM
Official Title
A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2018 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants
Detailed Description
Patient population will include preterm infants born at 24 - 36+6 weeks of gestation who are candidates for non-invasive respiratory support post extubation or as primary respiratory support after birth. They will be will be randomized to 2 groups: Heated Humidified High Flow Nasal Cannula (HHHFNC) and Nasal Intermittent Positive Pressure Ventilation (NIPPV). This will be a prospective unblinded randomized controlled study, designed as a non-inferiority trial. Primary outcome: The primary outcome will be rate of treatment failure (need for intubation) within 7 days of starting the study treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vapotherm arm
Arm Type
Experimental
Arm Description
Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA
Arm Title
NIPPV arm
Arm Type
Experimental
Arm Description
Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator
Intervention Type
Other
Intervention Name(s)
Vapotherm
Other Intervention Name(s)
Heated Humidified High Flow Nasal Cannula
Intervention Description
A form of non invasive ventilation used in newborns
Intervention Type
Other
Intervention Name(s)
NIPPV
Other Intervention Name(s)
Nasal Intermittent Positive Pressure Ventilation
Intervention Description
A form of non invasive ventilation used in newborns
Primary Outcome Measure Information:
Title
Rate of intubation within 7 days of starting the study treatment
Description
Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas
Time Frame
one week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures. Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation. Signed parental informed consent by one of the parents Exclusion Criteria: Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities Presence of a pneumothorax prior to enrollment Hemodynamic instability due to sepsis or hemorrhage Inability to obtain parental consent Shortage of suitable equipment Infants who were intubated solely for surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayala Gover, MD
Phone
972-528-396948
Email
ayalagover@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayala Gover, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayala Gover, MD
Phone
972-52-396948
Email
ayalagover@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants

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