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Completed

NCT Number: NCT01440647

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

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.

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Key information

Conditions

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

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants Hospital of RI

Providence, Rhode Island, 02905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extubation to NIPPV

Procedure

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

Other names: NIPPV

Extubation to CPAP

Procedure

After extubation infants were placed on CPAP

Other names: CPAP

Primary outcomes

  1. Number of Days Being Intubated

    Time frame: 30 days from birth

Secondary outcomes

  1. Percentage of Participants With Reintubation

    Time frame: 0-7 days post-extubation

    Reintubation rate is a measure of the efficacy of NIPPV.

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Sep 26, 2011
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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