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 @ 1:02 PM
Ignite Modification Date:
2025-12-24 @ 1:02 PM
NCT ID:
NCT04781361
Eligibility Criteria:
Inclusion Criteria are:
* Term newborns (\>37 + 0/7 weeks) aged 24 hours to 30 days with a normal baseline serum sodium level between 135-145 mmol/L,with a treatment plan to include IV fluids at \> 50% of maintenance
* Infants not received parenteral fluids in the last 24 hours before participation
* Infants receiving IV fluid administration at 50% to 100% of maintenance
Exclusion Criteria:
* Newborns with diagnoses that required specific fluid tonicity and volumes such as:
* Severe dehydration presenting with shock
* Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
* Renal insufficiency
* Adrenal insufficiency
* Diabetes mellitus and diabetes insipidus
* Hypoxic ischemic encephalopathy
* Major congenital anomaly
* Patients receiving diuretic therapy
* Patients with obvious edema
* Heart or liver failure, portal hypertension with acid
* Pre-post operative patients
* Infants receiving total parenteral nutritional therapy
* Other: all conditions that require non-standard liquid content and quantities
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
30 Days
Study:
NCT04781361
Study Brief:
Protocol Section:
NCT04781361