Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00296231
First received: February 22, 2006
Last updated: November 23, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Infant Respiratory Distress Syndrome
Respiratory Insufficiency
Apnea of Prematurity
Other: Nasal high frequency ventilation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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:
  • Transcutaneous CO2 Measurements as a Trend Throughout Intervention [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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


Enrollment: 14
Study Start Date: February 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296231

Locations
United States, Iowa
Children's Hospital of Iowa NICU
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Tarah T Colaizy, MD, MPH University of Iowa
  More Information

No publications provided

Responsible Party: Tarah Colaizy, MD, MPH, University of Iowa
ClinicalTrials.gov Identifier: NCT00296231     History of Changes
Other Study ID Numbers: 200508714
Study First Received: February 22, 2006
Results First Received: October 29, 2010
Last Updated: November 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
premature infants
very low birthweight infants
high frequency ventilation
nasal ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 01, 2014