Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Hospital Pediátrico de Sinaloa
66 participants
Mar 11, 2024
INTERVENTIONAL
Conditions
Summary
Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants. The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice. The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants.
Eligibility
Inclusion Criteria12
- 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 Criteria2
- Presence of liver diseases or malformations that cause cholestasis.
- All patients who have received medical treatment for cholestasis are excluded.
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Interventions
This study is a single-centre, non-blinded RCT in the NICU of Pediatric Hospital of Sinaloa, Northwest, Mexico. A total of 66 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (EN) for at least 10 days will be randomised to PNC o PNT after informed parental consent. In both groups, EN will be commenced as early as clinically feasible.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06366880