The Effect of Lactase-Treated Feeds on Feeding Intolerance in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean change from baseline in gastric residual volume
研究概览
简要总结
The purpose of this study is to evaluate whether adding lactase enzyme to milk feeds can improve feeding tolerance in preterm neonates. Preterm infants may have immature gastrointestinal function and reduced intestinal lactase activity, which may contribute to difficulty digesting lactose and symptoms of feeding intolerance. In this study, eligible preterm neonates will be randomly assigned to receive either lactase-treated milk feeds or placebo-treated milk feeds. Feeding tolerance will be assessed using clinical and nutritional parameters during the study period. The study will compare the two groups to determine whether lactase supplementation improves feeding tolerance and supports better progression of enteral feeding in preterm neonates. The hypothesis is that lactase-treated feeds will reduce feeding intolerance and facilitate achievement of adequate enteral feeding compared with placebo.
详细描述
This is a randomized, controlled, parallel-group interventional study designed to evaluate the effect of lactase-treated feeds on feeding intolerance in preterm neonates.
Preterm neonates are at increased risk of feeding intolerance because of gastrointestinal immaturity, delayed gastric emptying, immature intestinal motility, and incomplete development of digestive enzyme activity. Lactase activity may be relatively low in preterm infants, potentially resulting in incomplete lactose digestion and contributing to gastrointestinal symptoms associated with feeding intolerance.
Eligible preterm neonates will be enrolled according to predefined inclusion and exclusion criteria. Participants will be randomly allocated into two groups. The intervention group will receive milk feeds treated with lactase enzyme, while the control group will receive milk feeds treated with placebo. The placebo will consist of distilled water administered in an equivalent manner to the lactase preparation.
The study will evaluate feeding tolerance throughout the study period. Clinical parameters related to feeding tolerance will be recorded, including the occurrence and severity of feeding intolerance manifestations and the progression of enteral feeding. Nutritional and growth-related parameters will also be assessed according to the study protocol.
The primary objective is to determine whether lactase-treated feeds improve feeding tolerance in preterm neonates compared with placebo-treated feeds. Secondary objectives include evaluating the effect of lactase supplementation on the progression of enteral feeding and selected nutritional and growth outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants, investigators, and care providers were masked to treatment allocation. The lactase preparation and placebo were administered in identical conditions to maintain blinding throughout the study.
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <34 weeks.
- •≥2 symptoms suggestive of lactose intolerance: abdominal distension, abdominal pain, diarrhea, or diaper/nappy dermatitis.
- •Feeding intolerance defined by GRV >3 mL/kg or the specified vomiting/stool/abdominal-distension.
排除标准
- •Severe congenital malformations, including GI or cardiac defects.
- •NEC according to Bell's staging criteria.
- •Congenital diarrhea.
- •Hemodynamic instability requiring inotropes.
- •Amino-acid-based or lactose-free formula.
- •Guardian declines consent.
研究组 & 干预措施
Lacrase treated feeds
Preterm neonates randomly assigned to this group will receive enteral feeds treated with lactase enzyme
干预措施: Lactase enzyme (Drug)
Placebo
Preterm neonates randomly assigned to the control group will receive enteral feeds treated with an equivalent volume of sterile distilled water as placebo.
干预措施: Distilled water (Other)
结局指标
主要结局
Mean change from baseline in gastric residual volume
时间窗: From start of intervention till 2 wks
Gastric residual volume measured in milliliters before feeding and serially during the intervention period. The outcome will be assessed by comparing the change in gastric residual volume from baseline between the lactase-treated feed group and the placebo group.
Number of participants with abdominal distension
时间窗: From initiation of intervention to 2weeks
Abdominal distension assessed clinically by serial abdominal examination and abdominal circumference measurement during the intervention period. Participants with clinically evident abdominal distension will be recorded.
Number of participants with vomiting
时间窗: From initiation of intervention to 2 weeks
Vomiting episodes will be assessed by clinical observation during the intervention period and recorded for each participant.
Number of participants with diarrhea
时间窗: From initiation of intervention to 2 weeks
Diarrhea will be assessed clinically according to stool frequency and consistency during the intervention period and recorded for each participant.
Mean change from baseline in gastric residual volume
时间窗: From start of intervention till 2 weeks
Gastric residual volume measured in milliliters before feeding and serially during the intervention period. The outcome will be assessed by comparing the change in gastric residual volume from baseline between the lactase-treated feed group and the placebo group.
次要结局
- Mean change from baseline in body length(From initiation of the study intervention till 14 days)
- Mean change from baseline in body weight(From initiation of intervention to 2 weeks)
- Mean change from baseline in head circumference(From initiation of intervention to 14 days)
- Mean change from baseline in mid-upper arm circumference(From initiation of intervention to 14 days)
- Mean change from baseline in body length(From initiation of the study intervention till 2 weeks)
- Mean change from baseline in head circumference(From initiation of intervention to 2 weeks)
- Mean change from baseline in mid-upper arm circumference(From initiation of intervention to 2 weeks)