Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03944551
Eligibility Criteria:
Inclusion criteria:
Cases must meet the all following inclusion criteria for eligibility to be placed on bCPAP
* Hospitalization
* Age 12 months up to 5 years
* Fast breathing defined as: (Using a timing device to count rate for one full minute)
* ≥ 40 breath/min in a child aged 12-23 months
* ≥ 30 breaths/min in a child aged 2-5 years
* Any of the following respiratory signs: wheezing, nasal flaring, chest indrawing, cyanosis, grunting, head nodding, stridor and/or oxygen saturation \<90%.
* Informed written consent obtained Or
* Age 12 months up to 5 years
* Weight up to 20Kg
* With cough AND/OR any sign of difficult breathing Plus ONE general danger sign as follow:
* Not able to drink
* Persistent vomiting
* Convulsions
* Lethargy or unconscious
* Stridor in a calm child or
* Severe malnutrition
* Informed written consent obtained
Patients with the following conditions who meet eligible criteria can benefit from bCPAP:
* Bronchiolitis
* Respiratory viral infection
* Lung collapse / atelectasis
* Asthma exacerbation
* Patients with congenital heart disease with heart failure
* Malaria
* Severe Anemia
* Sepsis
* Meningitis
* Any patient with increased respiratory effort who meet the eligible criteria
We will include patients with progression to severe pneumonia during the hospitalization and those ones with chronic diseases too.
Definitions:
* Head nodding: a movement of the head synchronous with inspiration indicating severe respiratory distress
* Chest indrawing: lower chest wall goes in when the child breathes in
* Lethargy: is defined as "an infant who does not wake up on stimulation or, on waking, subsequently moves only on stimulation or does not move at all"
* Not able to drink: refers to "difficulty feeding or not feeding well (in an infant who was previously feeding well)"
* Convulsions: During the enrollment process, the danger sign for 'convulsions' will be collected by asking about the number and duration of seizures.
* Severe malnutrition Severe acute malnutrition is defined as per WHO as the presence of edema of both feet or severe wasting (weight-for-height/length \<-3SD) or mid upper arm circumference \< 115 mm \[19\]
* Progression to case definition during hospitalization: Cases that progress to severe pneumonia or meet the inclusion criteria previously mentioned during hospitalization but do not meet the definition during the time of admission because the disease is in the early stages of illness will be included.
* Chronic disease: Children with chronic lung or respiratory disease may be admitted to the study. We will not exclude patients from the study on the basis of a long history of symptoms.
Exclusion criteria:
Cases that meet any of the following exclusion criteria will be ineligible to enroll:
* Skin breakdown around the nose and mouth
* Facial trauma
* Persistent episodes of vomiting: more than 3 episodes in 1 hour.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
5 Years
Study:
NCT03944551
Study Brief:
Protocol Section:
NCT03944551