CLINICAL TRIAL

Treatment for Respiratory Distress Syndrome

Waitlist Available · < 18 · All Sexes · Mobile, AL

This study is evaluating whether a ventilator strategy which uses a higher ventilator rate may help premature infants breathe easier.

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About the trial for Respiratory Distress Syndrome

Eligible Conditions
Lung Injury · Preterm, Infant · Respiratory Distress Syndrome, Newborn · Respiratory Distress Syndrome · Bronchopulmonary Dysplasia · Ventilator-Induced Lung Injury · Syndrome

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Any baby who is born premature and has to be intubated and put on a ventilator for respiratory distress syndrome within 48 hours after birth is considered to have respiratory distress syndrome. show original
Inborn infants transferred to this center before 48 hours after birth are more likely to survive than outborn infants. show original
, No patient enrolled in the study had a ventilator rate ≤ 80 per minute. show original
Infants who have parents or legal guardians who have provided consent for their enrollment in the study will be included in the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 1-120 after birth
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 1-120 after birth
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1-120 after birth.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 15 secondary outcomes in patients with Respiratory Distress Syndrome. Measurement will happen over the course of Day 28 after birth.

Alive at day 28 after birth
DAY 28 AFTER BIRTH
Number of infants alive
DAY 28 AFTER BIRTH
Ventilator free
DAY 28 AFTER BIRTH
Number of infants ventilator free
DAY 28 AFTER BIRTH
Bronchopulmonary dysplasia
MEASURED AT 36 WEEKS' POSTMENSTRUAL AGE
Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation
MEASURED AT 36 WEEKS' POSTMENSTRUAL AGE
Postnatal steroids
BEFORE 36 WEEKS' POSTMENSTRUAL AGE
Rate of post natal steroids for bronchopulmonary dysplasia
BEFORE 36 WEEKS' POSTMENSTRUAL AGE
Bronchopulmonary dysplasia or death
18 TO 24 MONTHS AFTER BIRTH
Rate of moderate to severe neurodevelopmental impairment or death
18 TO 24 MONTHS AFTER BIRTH
Neurodevelopmental impairment
18 TO 24 MONTHS AFTER BIRTH
Rate of moderate to severe neurodevelopmental impairment in survivors < 27 weeks' gestation
18 TO 24 MONTHS AFTER BIRTH
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Who is running the study

Principal Investigator
C. T.
Colm Travers, Principal Investigator
University of Alabama at Birmingham

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of treatment?

Side effects of dexamethasone were more common than previously reported, with no clinically important consequences. Side effects were more common than in clinical trials. No dose escalation was associated with an increased likelihood of adverse effects. Patient counselling may be advisable.

Anonymous Patient Answer

What is respiratory distress syndrome?

Respiratory distress syndrome (RDS), also known as ‘respiratory failure’, ‘hyperinflation’ or ‘respiratory failure’, is a breathing disorder which occurs as a result of various types of injury that can damage the lung, such as a lung lesion, or irritation of the bronchi or lungs from other causes. The term is also commonly used to denote lung over ventilation. (...) RDS is a respiratory emergency. It is also called the distress signal that is heard when people in distress are unable to breathe.\n

Anonymous Patient Answer

What are common treatments for respiratory distress syndrome?

The use of neuromuscular blockade in preterm infants with respiratory distress syndrome remains controversial. The usefulness of corticosteroids in premature infants with respiratory distress syndrome remains unclear. Ventilatory support such as continuous positive airway pressure, intermittent positive pressure, and high-frequency oscillatory ventilation may improve the outcome of pulmonary hypoplasia in premature infants with respiratory distress syndrome.

Anonymous Patient Answer

How many people get respiratory distress syndrome a year in the United States?

Each year, 607,000 to 739,000 children and adults develop respiratory distress syndrome in the US, a value that is highly dependent on age, state, race, and medical insurance status.

Anonymous Patient Answer

What are the signs of respiratory distress syndrome?

Signs of respiratory distress syndrome include tachypnea (rapid breathing), tachypnoia (inadequate breathing) and cyanosis, particularly of the face, lips, mouth and extremities. Tachypnea is an early sign, and a rapid rate of breathing can be an indication of respiratory distress syndrome. If tachypnoia is not present at a given time, but becomes evident within 24 hours of onset of symptoms, the diagnosis is likely to be made. In many cases, this indicates the need for hospitalization, as is also true of cyanosis, which has to be looked for and monitored over 12 hours with periodic arterial blood gas analysis.

Anonymous Patient Answer

Can respiratory distress syndrome be cured?

Data from a recent study from the randomized controlled trials should encourage health authorities to intensify the research in this area for improving outcome. Further improvement of respiratory distress syndrome prevention and treatment is still indispensable to decrease the prevalence of this disease in the future.

Anonymous Patient Answer

What causes respiratory distress syndrome?

This multidisciplinary study identified a number of previously unrecognised causes in association with RDS. Further work is required to determine whether these have a detrimental, beneficial or no effect on outcomes.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

We found a number of small clinical trials in which most patients received either no treatment or had their own treatment. This is important as many of these small trials provided data on which to base future trials of medical treatments. These studies have led to the development of a new treatment programme for the disorder based on a pilot trial. It is also worthwhile obtaining information on the success of these treatment programmes. This was done using the power method. We were, however, unable to obtain reliable information for several of the conditions studied.

Anonymous Patient Answer

What is the average age someone gets respiratory distress syndrome?

Respiratory distress syndrome occurs mostly early in life and seldom occurs after 40 years of age. Age should generally be considered when making decisions about whether or not to administer mechanical ventilation for a patient with respiratory distress syndrome.

Anonymous Patient Answer

What does treatment usually treat?

Although more than half of reported cases of pediatric intensive care unit pneumonia that are treated with antibiotics do not respond to the antibiotic regimen, these cases are usually still cured. A combination of a macrolide and beta-lactam appears to be effective in pediatric ICU-acquired pneumonia. A high incidence of treatment failures reported in studies of resistant or refractory clinical pneumonia requires new approaches to the assessment and treatment of these patients.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

Based on past studies, the combination of steroids with antibiotics is considered effective at treating severe acute respiratory distress syndrome (ARDS). However, there is limited information on the use of antibiotics alone or with steroids in ARDS.

Anonymous Patient Answer

What is treatment?

Although the medical professionals are willing, knowledgeable about, and trained in treating neonates, unfortunately, for most of these ill infants/newborns the medical care is just too inadequate to keep us progressing and keep our patients alive, making us look on for a way to improve PNC services in this country.

Anonymous Patient Answer
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