Clinical trial NCT01270581: High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
Official title: High Flow Nasal Cannula vs Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transient Tachypnea of the Newborn
Keywords: transient tachypnea of the newborn
high flow nasal cannula
bubble nasal
continuous positive airway pressure
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 7
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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

Primary outcomes:
measure: Duration of Respiratory Support
timeFrame: average of 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrea Weintraub, MD
role: PRINCIPAL_INVESTIGATOR
References:
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