Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP

NCT01939067 | Withdrawn Phase 1

• 1 other identifier: 12-009882
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.

Conditions

Respiratory Distress; Lung Injury

Keywords

respiratory distress; Heated Humidified High Flow Nasal Cannula (HHHFNC); HHHFNC; noninvasive nasal continuous positive airway pressure (NCPAP); NCPAP

Outcome Measures

Primary Outcomes (1)

• Pulmonary mechanics and chest wall asynchrony measures.

  Pulmonary mechanics measures consisting of dynamic lung compliance, airway resistance, and work of breathing and chest wall asynchrony measures consisting of thoracoabdominal asynchrony, labored breathing index and rib cage to abdominal phase relation during the total breath are measured in preterm infants treated with HHHFNC and compared to the same measurements in preterm infants treated with NCPAP.

  2 years

Secondary Outcomes (3)

• Duration of respiratory support or oxygen use up to the time of discharge from the NICU.

  2 years

• The incidence of potential adverse outcomes associated with HHHFNC or NCPAP.

  2 years

• Time needed to establish full enteral feeds

  2 years

Study Arms (2)

HHHFNC

OTHER

Treatment of respiratory distress by Heated Humidified High Flow Nasal Cannula (HHHFNC). Escalation of the ventilatory support per protocol and the attending physician.

Device: Heated Humidified High Flow Nasal Cannula

NCPAP

OTHER

Treatment of respiratory distress by nasal continuous positive airway pressure (NCPAP). Escalation of the ventilatory support per protocol and the attending physician.

Device: Nasal Continuous Positive Airway Pressure

Interventions

Heated Humidified High Flow Nasal Cannula DEVICE

Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on HHHFNC and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.

HHHFNC

Nasal Continuous Positive Airway Pressure DEVICE

Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on NCPAP and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.

NCPAP

Eligibility Criteria

• Age: 2 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight greater than or equal to 1000 grams.
• Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).
• Candidate for non-invasive respiratory support as a result of:
• An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
• An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.
• Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.

You may not qualify if:

• Birth weight less than 1000 grams.
• Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
• Active air leak syndrome.
• Subjects will not be eligible if they are not considered viable.
• Infants with abnormalities of the upper and lower airways
• Infants with significant abdominal or respiratory malformations .

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Dyspnea; Lung Injury

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Soraya Abbasi, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 11, 2013
• Study Start: March 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

US (1)