Cholestasis in Newborn
Conditions
Keywords
Parenteral nutrition cycling, Incidence of colestasis, Incidence of hypoglycemia, Hospital-acquired infections, Randomised controlled trial
Brief 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.
Detailed description
Methods/design: 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. Primary outcomes Incidence of colestasis on Day 28 of admission. Secondary outcomes are total plasma bilirrubine profiles, the incidence of hypoglycemia, hospital-acquired infections, length of hospital/NICU stay, in-hospital all-cause mortality, weight, height and head circumference. Discussion: This RCT will examine the effects of NPTC versus late PNT in term and late preterm infants by comparing key biochemical and clinical outcomes and has the potential to identify underlying pathways for beneficial or harmful effects related to both treatments. Trial registration: 2022.HPS.DI.434 (3rd March 2024) Keywords: Parenteral nutrition cycling, Incidence of colestasis, incidence of hypoglycaemia, hospital-acquired infections, Randomised controlled trial.
Interventions
OTHERParenteral nutrition cycling
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.
Sponsors
Hospital Pediátrico de Sinaloa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cholestasis on Day 28 of admission. | Day 1 to 28 | Proportion of cholestasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| are total plasma bilirrubine profiles | Day 1 to 28 | mg/dl |
| the incidence of hypoglycaemia | Day 1 to 28 | mg/dl |
Countries
Mexico
Contacts
Primary ContactAna Karen Camargo Angulo, Dr.
Backup ContactClaudia Gamez, PhD
Outcome results
None listed