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

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ClinicalTrials.gov Identifier: NCT03853161
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ayala Gover, Carmel Medical Center

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

Condition or disease Intervention/treatment Phase
Preterm Infant Other: Vapotherm Other: NIPPV Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants
Actual Study Start Date : January 21, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 1, 2020

Arm Intervention/treatment
Experimental: Vapotherm arm
Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA
Other: Vapotherm
A form of non invasive ventilation used in newborns
Other Name: Heated Humidified High Flow Nasal Cannula

Experimental: NIPPV arm
Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator
Other: NIPPV
A form of non invasive ventilation used in newborns
Other Name: Nasal Intermittent Positive Pressure Ventilation




Primary Outcome Measures :
  1. Rate of intubation within 7 days of starting the study treatment [ Time Frame: one week ]
    Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03853161


Contacts
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Contact: Ayala Gover, MD 972-528-396948 ayalagover@gmail.com

Locations
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Israel
Carmel Medical Center Recruiting
Haifa, Israel
Contact: Ayala Gover, MD    972-52-396948    ayalagover@gmail.com   
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Ayala Gover, MD Carmel Medical Center

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Responsible Party: Ayala Gover, principal investigator, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT03853161     History of Changes
Other Study ID Numbers: CMC-17-0131-CTIL
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications