Clinical trial NCT01440647: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Keywords: Respiration, Artificial
Infant, Premature
Bronchopulmonary Dysplasia
Continuous Positive Airway Pressure
Non-Invasive Positive-Pressure Ventilation
Intermittent Positive-Pressure Ventilation
High-Frequency Ventilation
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 34
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Days Being Intubated
timeFrame: 30 days from birth
Secondary outcomes:
measure: Percentage of Participants With Reintubation
timeFrame: 0-7 days post-extubation
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital of RI
state: Rhode Island
Study officials:
affiliation: The Floating Hospital for Children at Tufts Medical Center
name: Olga A DeSimone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women and Infants Hospital of RI
name: Abbot R Laptook, MD
role: STUDY_DIRECTOR
References: