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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01440647
Other study ID # 07-0090
Secondary ID
Status Completed
Phase N/A
First received September 22, 2011
Last updated February 7, 2013
Start date November 2007
Est. completion date January 2010

Study information

Verified date February 2013
Source Women and Infants Hospital of Rhode Island
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date January 2010
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 48 Hours
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Extubation to NIPPV
After extubation infants were placed on NIPPV as soon as all the extubation criteria were met
Extubation to CPAP
After extubation infants were placed on CPAP

Locations

Country Name City State
United States Women and Infants Hospital of RI Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Days Being Intubated 30 days from birth No
Secondary Percentage of Participants With Reintubation Reintubation rate is a measure of the efficacy of NIPPV. 0-7 days post-extubation No
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