Using parenteral nutrition cycling to prevent cholestasis in newborns
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
This study is testing if a new way of giving nutrition through IV can help prevent liver problems in newborns who can’t tolerate regular feeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 1 Hour to 28 Days |
| Sex | All |
| Sponsor | Hospital Pediátrico de Sinaloa Government |
| Locations | 1 site (Culiacán, Sinaloa) |
| Trial ID | NCT06366880 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the benefits and risks of parenteral nutrition cycling (PNC) compared to total parenteral nutrition (TPN) in term and late preterm infants who are likely to have intolerance to enteral nutrition. Conducted in the NICU of the Pediatric Hospital of Sinaloa, the study will randomize 66 infants to receive either PNC or TPN after obtaining informed parental consent. The primary outcome is the incidence of cholestasis by Day 28 of admission, while secondary outcomes include various clinical and biochemical measures such as hypoglycemia and hospital-acquired infections.
Who should consider this trial
Good fit: Ideal candidates are infants born at or after 34 weeks of gestation who are expected to have intolerance to enteral nutrition for at least 10 days.
Not a fit: Patients with existing liver diseases or malformations causing cholestasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce the incidence of cholestasis in newborns receiving parenteral nutrition.
How similar studies have performed: While there is limited evidence regarding the benefits of parenteral nutrition cycling in this specific population, variations in clinical practice suggest that this approach is novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chylothorax * Intestinal obstruction * Intestinal malrotation * Intestinal intussusception * Gastroschisis * Intestinal volvulus * Duodenal atresia * Enterocolitis * Sepsis * Septic shock * Prolonged fast * Authorization of the study by parents Exclusion Criteria: * Presence of liver diseases or malformations that cause cholestasis. * All patients who have received medical treatment for cholestasis are excluded.
Where this trial is running
Culiacán, Sinaloa
- Hospital Pediatrico de Sinaloa — Culiacán, Sinaloa, Mexico (Recruiting)
Study contacts
- Study coordinator: Ana Karen Camargo Angulo, Dr.
- Email: anakarencamargo96@gmail.com
- Phone: 6681890586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.