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

Women and Infants Hospital of Rhode Island

Status: Completed

Conditions: Bronchopulmonary Dysplasia

Treatments: Procedure: Extubation to NIPPV; Procedure: Extubation to CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01440647

07-0090

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

NIPPV

Experimental group

Description:

Extubation to NIPPV (nasal intermittent positive pressure ventilation)

Treatment:

Procedure: Extubation to NIPPV

CPAP

Active Comparator group

Description:

After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life

Treatment:

Procedure: Extubation to CPAP