Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Apnea of Prematurity; Infant Respiratory Distress Syndrome
• Intervention / Treatment: Other: Nasal high frequency ventilation

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Children's Hospital of Iowa NICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values	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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcutaneous CO2 Measurements as a Trend Throughout Intervention	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	2 hours

Collaborators and Investigators

• Sponsor: Tarah T Colaizy
• Investigators: Principal Investigator: Tarah T Colaizy, MD, MPH, University of Iowa

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: February 22, 2006
• First Submitted That Met QC Criteria: February 22, 2006
• First Posted (Estimate): February 24, 2006

Study Record Updates

• Last Update Posted (Actual): February 9, 2018
• Last Update Submitted That Met QC Criteria: January 14, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: nasal ventilation; very low birthweight infants; premature infants; high frequency ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 200508714