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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Olga Sorina, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01440647
First received: September 22, 2011
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Bronchopulmonary Dysplasia
Procedure: Extubation to NIPPV
Procedure: Extubation to CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Number of Days Being Intubated [ Time Frame: 30 days from birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With Reintubation [ Time Frame: 0-7 days post-extubation ] [ Designated as safety issue: No ]
    Reintubation rate is a measure of the efficacy of NIPPV.


Enrollment: 34
Study Start Date: November 2007
Study Completion Date: January 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: CPAP

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440647

Locations
United States, Rhode Island
Women and Infants Hospital of RI
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Olga Sorina, Principal Investigator, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01440647     History of Changes
Other Study ID Numbers: 07-0090
Study First Received: September 22, 2011
Results First Received: December 26, 2012
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:
Respiration, Artificial
Infant, Premature
Bronchopulmonary Dysplasia
Continuous Positive Airway Pressure
Non-Invasive Positive-Pressure Ventilation
Intermittent Positive-Pressure Ventilation
High-Frequency Ventilation

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 14, 2014