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

NCT01440647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-03-12

Study results available
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Summary

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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

PROCEDURE

Extubation to NIPPV

After extubation infants were placed on NIPPV as soon as all the extubation criteria were met

PROCEDURE

Extubation to CPAP

After extubation infants were placed on CPAP

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Olga A DeSimone, MD · The Floating Hospital for Children at Tufts Medical Center

  • Abbot R Laptook, MD · Women and Infants Hospital of RI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-07-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01440647 on ClinicalTrials.gov