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

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Bronchopulmonary dysplasia
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Brief Title

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

Official Title

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

Brief 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.

Study Type

Interventional

Primary Outcome

Number of Days Being Intubated

Secondary Outcome

 Percentage of Participants With Reintubation

Condition

Bronchopulmonary Dysplasia

Intervention

Extubation to NIPPV

Study Arms / Comparison Groups

 NIPPV
Description:  Extubation to NIPPV (nasal intermittent positive pressure ventilation)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

34

Start Date

November 2007

Completion Date

January 2010

Primary Completion Date

July 2009

Eligibility 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.

Gender

All

Ages

N/A - 48 Hours

Accepts Healthy Volunteers

No

Contacts

Olga A DeSimone, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01440647

Organization ID

07-0090

Responsible Party

Principal Investigator

Study Sponsor

Women and Infants Hospital of Rhode Island

Study Sponsor

Olga A DeSimone, MD, Principal Investigator, The Floating Hospital for Children at Tufts Medical Center

Verification Date

February 2013