N/A
N=34
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT01440647 ↗Enrolled (actual)
34
Serious AEs
14.7%
Results posted
Mar 2013
Primary outcome: Primary: Number of Days Being Intubated — 12.4; 6.2 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Extubation to NIPPV (Procedure); Extubation to CPAP (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Women and Infants Hospital of Rhode Island
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days Being Intubated |
12.4; 6.2 | — |
| SECONDARY Percentage of Participants With Reintubation |
67; 28 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01440647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.