PEEP and V/Q Mismatch in Premature Infants

Infant, Premature, Diseases Clinical Trial

Official title:

Selecting PEEP in Ventilated Premature Infants by Reducing Ventilation/Perfusion Mismatch: a Pilot Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03109613
• Other study ID #: 17-013702
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 11, 2016
• Est. completion date: August 8, 2018

Study information

• Verified date: November 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 8, 2018
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

1. Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission

2. Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.

3. Presence of endotracheal intubation and invasive mechanical ventilation

4. Less than or equal to 28 days chronologic age

5. Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.

Exclusion Criteria:

1. Congenital anomalies, as determined by the clinical supervising physician

2. Current of prior air leak syndrome, as determined by the clinical supervising physician.

3. Non-English speaking parents

4. Non-viable birth, as determined by the clinical supervising physician

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Premature Birth
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Respiratory Insufficiency Syndrome of Newborn

Intervention

Device:
• Positive end-expiratory pressure (PEEP)
level changes as per arm description

Locations

Country	Name	City	State
United States	Christiana Care Health System	Newark	Delaware
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility assessed by rate of successfully study enrollment and completion	Rate of successfully study enrollment and completion	Full enrollment (12 subjects)
Secondary	Ventilation/perfusion mismatch	Measured by non-invasive computerized technique based of curvilinear characteristics generated by a best-fit curve connection the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs	10-20 minutes following each PEEP level change