PEEP and V/Q Mismatch in Premature Infants

Phase 1

Terminated

• Conditions: Infant, Premature, Diseases; Respiratory Insufficiency Syndrome of Newborn
• Interventions: Device: Positive end-expiratory pressure (PEEP)

• Registration Number: NCT03109613
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-11
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-12
• Primary Completion: 2018-08-08
• Study Completion: 2018-08-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positive end-expiratory pressure (PEEP) level changes	Positive end-expiratory pressure (PEEP)	Sequential changes in PEEP level within range of 4-8 cm H2O followed by measurement of V/Q mismatch at each level.

Primary Outcome Measures

Name	Time	Method
Feasibility assessed by rate of successfully study enrollment and completion	Full enrollment (12 subjects)	Rate of successfully study enrollment and completion

Secondary Outcome Measures

Name	Time	Method
Ventilation/perfusion mismatch	10-20 minutes following each PEEP level change	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

Trial Locations

Locations (3)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States