Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator

February 7, 2013 updated by: Olga Sorina, Women and Infants Hospital of Rhode Island

Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study

Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital of RI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria.
  • Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life.
  • Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz.
  • Infants who have never been previously extubated.

Exclusion Criteria:

  • Infants enrolled in competing trials.
  • Participation refused by parent/attending physician/ parent unavailable for consent.
  • Infants with any major congenital abnormality.
  • Postoperative patients from any surgery.
  • Infants in extremis/decided upon not to receive intensive care.
  • Ventilator settings lower than the intervention group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIPPV
Extubation to NIPPV (nasal intermittent positive pressure ventilation)
Procedure: Extubation to NIPPV
After extubation infants were placed on NIPPV as soon as all the extubation criteria were met
Other Names:
  • NIPPV
Active Comparator: CPAP
After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life
Procedure: Extubation to CPAP
After extubation infants were placed on CPAP
Other Names:
  • CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Days Being Intubated
Time Frame: 30 days from birth
30 days from birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Reintubation
Time Frame: 0-7 days post-extubation
Reintubation rate is a measure of the efficacy of NIPPV.
0-7 days post-extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Investigators

  • Principal Investigator: Olga A DeSimone, MD, The Floating Hospital for Children at Tufts Medical Center
  • Study Director: Abbot R Laptook, MD, Women and Infants Hospital of RI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimate)

September 26, 2011

Study Record Updates

Last Update Posted (Estimate)

March 12, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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