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

NCT01440647 | Completed Results DMC

• 1 other identifier: 07-0090
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Respiration, Artificial; Infant, Premature; Bronchopulmonary Dysplasia; Continuous Positive Airway Pressure; Non-Invasive Positive-Pressure Ventilation; Intermittent Positive-Pressure Ventilation; High-Frequency Ventilation

Outcome Measures

Primary Outcomes (1)

• Number of Days Being Intubated

  30 days from birth

Secondary Outcomes (1)

• Percentage of Participants With Reintubation

  0-7 days post-extubation

Study Arms (2)

NIPPV

EXPERIMENTAL

Extubation to NIPPV (nasal intermittent positive pressure ventilation)

Procedure: Extubation to NIPPV

CPAP

ACTIVE COMPARATOR

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

Procedure: Extubation to CPAP

Interventions

Extubation to NIPPV PROCEDURE

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

Also known as: NIPPV

NIPPV

Extubation to CPAP PROCEDURE

After extubation infants were placed on CPAP

Also known as: CPAP

CPAP

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital of RI

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Respiratory Aspiration; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Abbot R. Laptook, MD, Professor of Pediatrics The Warren Alpert Medical School of Brown University M
• Organization: Women & Infants Hospital of Rhode Island

ALaptook@WIHRI.org

401-274-1122

Study Officials

• Olga A DeSimone, MD

  The Floating Hospital for Children at Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Abbot R Laptook, MD

  Women and Infants Hospital of RI

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 26, 2011
• Study Start: November 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 12, 2013
• Results First Posted: March 12, 2013

Record last verified: 2013-02

Locations

US (1)