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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04801251
Eligibility Criteria:
Inclusion Criteria:
* • Abnormal heart rate (\< 90/min or \< 160 per min )
* Comfortable tachypnea ( RR \> 60/min without other manifestations of respiratory distress)
* Abnormal heart sounds (muffled, accentuated, single )
* Abnormal precordial activity
* Murmur: ( ≥ grade 3 intenisty, holosystolic timing, maximum intensity at upper left sternal border or with upright positing, diastolic murmur, harsh or blowing quality )
* Abnormal oxygen saturation \<90% in any extremity Oxygen saturation gradient \> 3% difference in extremities.
* Blood pressure gradient \>10 mmHg higher in arms \>10 mmHg lower in legs
* Abnormal femoral pulses
* Weakened pulses
* Absent pulses
* Hepatomegaly
* Family history of cardiac disease
Exclusion Criteria:
* Newborns with disorders affecting the heart as anemia, septicemia, respiratory disorders as respiratory distress syndrome, pneumonia, hypoplastic lung, renal impairment, hypertension, metabolic disease, syndromatic CHF
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
28 Days
Study:
NCT04801251
Study Brief:
Protocol Section:
NCT04801251