The PROSpect Study: A Pediatric Study to Test the Best Breathing Position for Children When They Are Sick
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Age: -1 to 18 years old
Gender:
Any
Healthy Volunteers: No
Keywords: pediatric breathing, breathing
Type: Other study
Target:
24 Participants
Investigator:
Description
This study is being done to learn the best way to help children breathe when they are sick.

When children’s lungs are very sick they are on a machine to help them breathe. There are different types of breathing machines that can be used.

The two types are usual or high frequency:
1) A usual breathing machine imitates a person’s normal breathing.
2) A high frequency breathing machine delivers fast and shallow breaths.

There are also different positions a child can be in while on a breathing machine:
1) Lying on their back with a slight change in position every two hours.
2) Lying on their stomach for at least 16 hours each day with a slight change in position every 2 hours.

When needed for medical care, your child will be turned on their back, and then returned to lying on his or her stomach. At UC Davis, we use both types of breathing machines and place children in both positions.

The main purpose of this study is to find out if one approach is better than others in reducing the number of days a child spends on a breathing machine. The length of time your child spends on the breathing machine may be shorter or longer from taking part in this study.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Pediatric patients ≥2 weeks of age (≥42 weeks post gestational age) and <18 years of age

  • Intubated and mechanically ventilated with severe PARDS for <48 hours per PALICC guidelines (chest imaging consistent with acute pulmonary parenchymal disease and OI ≥16 or OSI ≥12.3). We require two consecutive blood gases meeting severe PARDS criteria (separated by at least 4 ± 2 hours during which time the clinical team is actively working to recruit lung volume and optimize the patient’s hemodynamic status per PALICC guidelines; specifically, incremental decremental PEEP changes to optimize lung volume. To facilitate early identification of PARDS, the OSI may be used in lieu of the first blood gas in the absence of a functional arterial line.

Exclusion criteria:

  • Perinatal related lung disease

  • Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis

  • Respiratory failure explained by cardiac failure or fluid overload

  • Cyanotic heart disease

  • Cardiomyopathy

  • Unilateral lung disease

  • Primary pulmonary hypertension

  • Intubated for status asthmaticus

  • Obstructive airway disease (e.g., bronchiolitis or disease characterized by hypercapnia with FiO2 <0.30 and/or evidence of increased resistance visible on the flow – time scalar and/or presence of intrinsic PEEP)

  • Active air leak

  • Bronchiolitis obliterans

  • Post hematopoietic stem cell transplant

  • Post lung transplant

  • Home ventilator (including noninvasive) or home oxygen dependent

  • Neuromuscular respiratory failure

  • Critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass)

  • Facial surgery or trauma in previous 2 weeks

  • Head trauma (managed with hyperventilation)

  • Intracranial bleeding

  • Unstable spine, femur or pelvic fractures

  • Acute abdominal process/open abdomen

  • Morbid obesity (2w-24 months: WHO weight-for-length/height z-score ≥+3; ≥2 years: WHO body mass index (BMI)-for-age z-score ≥+3)

  • Received either prone positioning or any high-frequency mode of MV with current illness

  • Supported on ECMO during the current admission

  • Family/medical team not providing full support (patient treatment considered futile)

  • Previously enrolled in current study

  • Enrolled in any other interventional clinical trial not approved for co-enrollment

  • Known pregnancy

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The study will take 4 years to complete.
Recruitment period
From Sept. 3, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Sauers-Ford, Hadley
Research Topic
Conditions:
  • Acute Respiratory Distress Syndrome in Children

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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