Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Incidence of cholestasis on Day 28 of admission.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chylothorax
- •Intestinal obstruction
- •Intestinal malrotation
- •Intestinal intussusception
- •Gastroschisis
- •Intestinal volvulus
- •Duodenal atresia
- •Enterocolitis
- •Septic shock
- •Prolonged fast
- •Authorization of the study by parents
排除标准
- •Presence of liver diseases or malformations that cause cholestasis.
- •All patients who have received medical treatment for cholestasis are excluded.
结局指标
主要结局
Incidence of cholestasis on Day 28 of admission.
时间窗: Day 1 to 28
Proportion of cholestasis
次要结局
- the incidence of hypoglycaemia(Day 1 to 28)
- are total plasma bilirrubine profiles(Day 1 to 28)
研究者
Camargo Angulo Ana Karen
Dr.
Hospital Pediátrico de Sinaloa