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

Not Applicable

Completed

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Procedure: Extubation to NIPPV; Procedure: Extubation to CPAP

• Registration Number: NCT01440647
• Lead Sponsor: Women and Infants Hospital of Rhode Island

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-07
• Study Completion: 2010-01
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Results First Submitted: 2012-12-26
• Status Verified: 2013-02
• Results First Submitted QC: 2013-02-07
• Last Update Submitted: 2013-02-07
• Results First Posted: 2013-03-12
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIPPV	Extubation to NIPPV	Extubation to NIPPV (nasal intermittent positive pressure ventilation)
CPAP	Extubation to CPAP	After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life

Primary Outcome Measures

Name	Time	Method
Number of Days Being Intubated	30 days from birth

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Reintubation	0-7 days post-extubation	Reintubation rate is a measure of the efficacy of NIPPV.

Trial Locations

Locations (1)

Women and Infants Hospital of RI; 🇺🇸 Providence, Rhode Island, United States