Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

NCT ID: NCT00296231

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-02-29

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.

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.

Conditions

Infant Respiratory Distress Syndrome; Respiratory Insufficiency; Apnea of Prematurity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nasal high frequency ventilation

Intervention Type: OTHER

use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.

Interventions

Nasal high frequency ventilation

use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tarah T Colaizy

OTHER

Sponsor Role: lead

Responsible Party

Tarah T Colaizy

Associate Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tarah T Colaizy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

Children's Hospital of Iowa NICU

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

200508714

Identifier Type: -

Identifier Source: org_study_id