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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440647
• Other study ID #: 07-0090
• 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

• Bronchopulmonary Dysplasia

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