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Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00296231
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : December 22, 2010
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Tarah T Colaizy, University of Iowa

Study Description
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Brief Summary:
The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.

Condition or disease Intervention/treatment Phase
Infant Respiratory Distress Syndrome Respiratory Insufficiency Apnea of Prematurity Other: Nasal high frequency ventilation Phase 1

Detailed Description:
Prolonged mechanical ventilation is frequently needed to treat respiratory insufficiency and apnea in very low birthweight (VLBW, <1500 g) preterm infants. Endotracheal intubation and mechanical ventilation carry many risks including potentially fatal air leaks and ventilator-associated pneumonias. Less-invasive methods of respiratory support are needed to minimize these risks while supporting the convalescing preterm infant. We propose to test the effectiveness of nasal high-frequency ventilation (NHFV) in stable neonates with mild respiratory acidosis who are dependent on nasal continuous positive airway pressure for respiratory support (CPAP). Nasal high frequency ventilation may be effective in decreasing rates of reintubation for apnea or respiratory insufficiency in VLBW infants. We will enroll 60 stable VLBW infants who are currently being treated with nasal CPAP and who have mild respiratory acidosis. Twenty patients will be assigned to each ventilator under investigation. Nasal high frequency ventilation will be applied at the same mean airway pressure as the patients' previous CPAP support. The amplitude on nasal high frequency ventilation will be adjusted to achieve adequate shaking of the chest wall. Blood gas measurements, transcutaneous continuous pCO2 monitoring, continuous pulse oximetry, and chest x-rays will be used to assess safety and efficacy. Study power has been calculated to detect a difference (drop or rise) in partial pressure of CO2 (pCO2) equal to two-thirds of the standard deviation of pCO2 change reported in another study (van der Hoeven et al., 1998), which is a clinically relevant difference.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
Study Start Date : February 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nasal High Frequency Ventilation
Stable infants born at less than 1501 g who are at least 7 days old and undergoing nasal continuous positive airway pressure treatment.
 Other: Nasal high frequency ventilation
use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.


Outcome Measures
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Primary Outcome Measures :
  1. pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values [ Time Frame: 2 hours ]
    Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control.


Secondary Outcome Measures :
  1. Transcutaneous CO2 Measurements as a Trend Throughout Intervention [ Time Frame: 2 hours ]
    We used a transcutaneous CO2 monitor (TCOM) as a safety device throughout the study. We analyzed the change in TCOM readings recorded every 30 minutes (5 measurements) to determine safety


Eligibility Criteria
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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • birthweight less than 1500 g
  • Age >7 days
  • Free of severe intraventricular hemorrhage (Grade III-IV)
  • requiring nasal continuous positive airway pressure with a stable compensated respiratory acidosis (pH 7.25 - 7.45, pCO2 > 43 mm Hg),
  • medically stable.

Exclusion Criteria:

  • major congenital anomalies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296231


Locations
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United States, Iowa
Children's Hospital of Iowa NICU
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Tarah T Colaizy
Investigators
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Principal Investigator: Tarah T Colaizy, MD, MPH University of Iowa
More Information
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Responsible Party: Tarah T Colaizy, Associate Professor of Pediatrics, University of Iowa
ClinicalTrials.gov Identifier: NCT00296231    
Other Study ID Numbers: 200508714
First Posted: February 24, 2006    Key Record Dates
Results First Posted: December 22, 2010
Last Update Posted: February 9, 2018
Last Verified: January 2018
Keywords provided by Tarah T Colaizy, University of Iowa:
premature infants
very low birthweight infants
high frequency ventilation
nasal ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases