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Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe (Neovest)

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ClinicalTrials.gov Identifier: NCT03510169
Recruitment Status : Not yet recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:

The NeoVest delivery device is a wearable vest/shell that surrounds the infant's abdomen. It was developed using serial body measurements of infants previously admitted to the St. Michael's Hospital NICU (REB #15-183). It gently pulls on the abdomen by applying negative pressure, thereby displacing the diaphragm. The materials used for the NeoVest are lightweight and suitable for the infants' sensitive skin.

The AIM of the present study is to demonstrate the feasibility of applying negative pressure NIV, that is synchronized and proportional to the infant's respiratory demand. The preliminary data on feasibility can be used to apply for larger grants from the CIHR, for a study of the NeoVest in smaller premature infants.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome TTN RDS of Prematurity Respiratory Distress, Newborn Device: NeoVest Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Novel Use of Negative Pressure Assist in Neonates With Respiratory Distress: a Feasibility Study Using Neovest
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: NeoVest
Negative pressure ventilation using NeoVest
Device: NeoVest
Negative pressure ventilation with NeoVest
Other Name: Negative Pressure Ventilation




Primary Outcome Measures :
  1. Feasibility of negative pressure ventilation with NeoVest [ Time Frame: 22 minutes ]
    Ability to provide negative pressure ventilation with the NeoVest


Secondary Outcome Measures :
  1. Diaphragm Electrical Activity [ Time Frame: Will be obtained every 1-5 minutes, or following any change in respiratory support ]
    Obtained from Edi catheter

  2. Respiratory Rate [ Time Frame: Will be obtained every 1-5 minutes, or following any change in respiratory support ]
    Breaths per minute

  3. Heart Rate [ Time Frame: Will be obtained every 1-5 minutes, or following any change in respiratory support ]
    Beats per minute

  4. Oxygen Saturation [ Time Frame: Will be obtained every 1-5 minutes, or following any change in respiratory support ]
    Percent oxygen saturation

  5. Transcutaneous Carbon Dioxide Level [ Time Frame: Will be obtained every 1-5 minutes, or following any change in respiratory support ]
    Transcutaneous meassurement in mmHg

  6. Blood Pressure [ Time Frame: Will be obtained every 1-5 minutes, or following any change in respiratory support ]
    Obtained with blood pressure cuff in mmHg



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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 infants, admitted to Neonatal Intensive Care Unit (NICU) at St. Michael's Hospital
  • >1.5kg birthweight
  • Clinically stable, with symptoms of respiratory distress (due to transient tachypnea of the newborn, respiratory distress syndrome, etc.)
  • Stable on nasal CPAP (5-8cm H2O) for a minimum of 6 hours
  • Within the first two weeks of life

Exclusion Criteria:

  • Infants with FiO2 requirements >0.35
  • Infants with clinically significant apnoea or bradycardia (> 2 A&B in last hour, or apnea >20 sec, or bradycardia requiring significant stimulation)
  • Infants with hemodynamic instability (mean BP < weeks GA), or any infant requiring fluid boluses and/or inotropic medications
  • Infants with genetic conditions or dysmorphic facial features
  • Infants that have been recently extubated in the last 48 hours
  • Infants in whom placement of the NG tube is contra-indicated
  • Infants with any clinical suspicion of upper airway distress such as symptoms of stridor
  • Infants with abdominal wall defects and other visible abnormalities of the abdomen or chest

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): NCT03510169


Contacts
Contact: Douglas Campbell, MD 416-864-6060 ext 6560 campbelld@smh.ca

Sponsors and Collaborators
St. Michael's Hospital, Toronto

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03510169     History of Changes
Other Study ID Numbers: 17-282Neovest
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases