TPN in Preterm Clinical Trial
Official title:
Safety and Efficacy Evaluation of TPN in Preterm Neonates in NICU of Cairo University Children Hospital
| Verified date | January 2021 |
| Source | Cairo University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aim of this work is evaluation of electrolytes and minerals homeostasis and occurrence of complications among preterm babies receiving total parenteral nutrition, and admitted to the neonatal intensive care units of Cairo University Children hospitals.
| Status | Active, not recruiting |
| Enrollment | 200 |
| Est. completion date | December 7, 2021 |
| Est. primary completion date | March 7, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A to 1 Month |
| Eligibility | Inclusion Criteria: - All preterm infants with gestational age < 34 weeks, Receiving total parenteral nutrition. Normal serum magnesium. Exclusion Criteria: - Any full-term neonates Any patient with TORCH infection, chromosomal, metabolic disorders or surgical abnormality of the hepatobiliary system |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of Medicine | Cairo | Almanyal |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | electrolyte and mineral disturbance associated with TPN in preterm receiving it | NA, K, MG, P, CA. | 14 days | |
| Secondary | prevalence of cholestasis and sepsis in preterm receiving TPN | clinical and laboratory examination | 14 days |