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High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01270581
First received: December 21, 2010
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN) when compared to the standard of care modality (NCPAP).


Condition Intervention
Transient Tachypnea of the Newborn
Other: High Flow Nasal Cannula
Other: Bubble Nasal CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Flow Nasal Cannula vs Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • duration of respiratory support [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • esophageal pressure [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
    determination and comparison of esophageal pressure as an indirect measurement of positive distending pressure generated by NCPAP and HFNC

  • time to first enteral feed [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • time to first oral feed [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • length of stay [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • weight gain [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • frequency of desaturations [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • air leak syndrome [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • nasal irritation [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • local columella necrosis [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • need for endotracheal intubation [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]
  • need for mechanical ventilation [ Time Frame: average of 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: July 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Flow Nasal Cannula
Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
Other: High Flow Nasal Cannula
Humidified high flow nasal cannula (HFNC) has emerged as an alternative respiratory modality for late preterm newborns with respiratory distress. Like NCPAP, oxygen is delivered to the infant via nasal prongs and provides a continuous distending pressure. Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7.
Active Comparator: Control Group- Bubble Nasal CPAP
NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
Other: Bubble Nasal CPAP
NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.

Detailed Description:

Transient Tachypnea of the Newborn, fetal lung fluid retention causing poor lung compliance and atelectasis, is a common entity in neonates ≥ 36 weeks in our unit. Currently our standard of care includes using the respiratory modality of bubble nasal continuous positive airway pressure (BNCPAP) to support these neonates during this illness. BNCPAP provides positive distending pressure to recruit alveoli and prevent atelectasis, however, it is associated with air leak (pneumothorax, pneumomediastinum), nasal irritation and necrosis, and intolerance. HFNC is another respiratory modality that uses high flow gas that also provides positive distending pressure and thus prevents atelectasis. This modality does not cause nasal irritation or necrosis and has a minimal risk of air leak. We postulate that HFNC is a superior modality to BNCPAP in treating neonates ≥ 36 weeks with TTN. This will be determined by comparing the duration of respiratory support (in hours) for newborns ≥ 36 weeks gestation with a diagnosis to TTN randomized to receive either NCPAP or HFNC for respiratory care.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestational age ≥ 35 weeks
  • diagnosis of TTN, defined as respiratory rate >60, presence of subcostal and /or intercostal retractions, nasal flaring, grunting, oxygen saturations 70-93% on room air, and radiological evidence of perihilar streaking and patchy infiltrates
  • admission to the NICU at Mount Sinai hospital within first 24 hours of life

Exclusion Criteria:

  • gestational age < 35 weeks
  • history of thick meconium stained fluid and/or diagnosis of meconium aspiration syndrome
  • diagnosis of major congenital pulmonary or cardiac anomalies
  • initial CXR demonstrating air leak
  • respiratory distress first occurring after 24 hours of life
  • presumptive diagnosis of RDS as indicated by the need for FiO2 > 40%, severe retractions and grunting with poor air entry, and diffuse alveolar consolidation on chest radiograph
  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: NCT01270581

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Loren M DeLuca, DO    212-241-6186    loren.deluca@mssm.edu   
Contact: Andrea Weintraub, MD    212-241-6186    andrea.weintraub@mssm.edu   
Principal Investigator: Andrea Weintraub, MD         
Sub-Investigator: Loren M DeLuca, DO         
Sub-Investigator: Robert Green, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Andrea Weintraub, MD Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01270581     History of Changes
Other Study ID Numbers: 10-0603
Study First Received: December 21, 2010
Last Updated: January 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
transient tachypnea of the newborn
high flow nasal cannula
bubble nasal
continuous positive airway pressure

Additional relevant MeSH terms:
Tachypnea
Transient Tachypnea of the Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 25, 2014