Respiratory Transition Without Continuous Positive Airway Pressure in Term Infants With Mild Respiratory Distress: A Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). The secondary aim is to determine the incidence of pneumothorax (PTX) for all term neonates assessed to have mild respiratory distress in the delivery room (DR).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 9 months
Healthy Volunteers: f
View:
• Full term infants (37 weeks + 0days to 41 weeks +6days gestational age)
• Born via scheduled c-sections without labor
• Who develop mild respiratory distress, defined as nasal flaring or, intermittent grunting, and/or mild retractions and/or +/- mild tachypnea ( respiratory rate 61-90).
Locations
United States
New Jersey
Hackensack Univeristy Medical Center
RECRUITING
Hackensack
Contact Information
Primary
Jeanette Buljevich Haugh
jeanette.haugh@hmhn.org
551-996-5336
Time Frame
Start Date: 2023-01-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 35
Treatments
Active_comparator: Standard of care
Continuous positive airway pressure (CPAP) is administered for mild respiratory distress
Experimental: Watchful waiting
Neonates with mild respiratory distress are observed for 20 minutes, and CPAP is administered at 25 minutes of life if respiratory distress continues or earlier if moderate to severe respiratory distress occurs
Related Therapeutic Areas
Sponsors
Leads: Hackensack Meridian Health