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

NCT ID: NCT01440647

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-01-31

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.

Conditions

Bronchopulmonary Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NIPPV

Extubation to NIPPV (nasal intermittent positive pressure ventilation)

Group Type: EXPERIMENTAL

Extubation to NIPPV

Intervention Type: PROCEDURE

After extubation infants were placed on NIPPV as soon as all the extubation criteria were met

CPAP

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

Group Type: ACTIVE_COMPARATOR

Extubation to CPAP

Intervention Type: PROCEDURE

After extubation infants were placed on CPAP

Interventions

Extubation to NIPPV

After extubation infants were placed on NIPPV as soon as all the extubation criteria were met

Intervention Type: PROCEDURE

Extubation to CPAP

After extubation infants were placed on CPAP

Intervention Type: PROCEDURE

Other Intervention Names

NIPPV; CPAP

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.

• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Olga Sorina

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga A DeSimone, MD

Role: PRINCIPAL_INVESTIGATOR

The Floating Hospital for Children at Tufts Medical Center

Abbot R Laptook, MD

Role: STUDY_DIRECTOR

Women and Infants Hospital of RI

Locations

Women and Infants Hospital of RI

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

07-0090

Identifier Type: -

Identifier Source: org_study_id