Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants Based on Early Gut Microbiota-Host Interaction Patterns: A Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- The incidence rate of extrauterine growth restriction (EUGR) among participants at the time of hospital discharge
研究概览
简要总结
The goal of this clinical trial is to ascertain whether oropharyngeal administration of colostrum contributes to postnatal growth in very preterm infants (those born before 32 weeks of gestation). The main questions it aims to answer are:
Can Oropharyngeal administration of colostrum effectively lower the incidence rate of extrauterine growth restriction (EUGR) in participants? Does oropharyngeal colostrum intervention bring about changes in the early gut microbiota of participants? Researchers will conduct a comparative analysis between colostrum and a placebo (normal saline) to investigate whether oropharyngeal administration of colostrum has a beneficial effect on the postnatal growth of participants.
Participants will:
Initiation of oropharyngeal colostrum administration will take place within 48 - 72 hours after birth, and the treatment will be administered continuously for a period of 5 days.
Stool samples will be collected from the participants both before and after the intervention.
Participants will be required to maintain a diary to document their basic characteristics and clinical outcomes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <32 weeks and birth weight <1500 g;
- •admitted to the NICU of one of the five hospitals mentioned above within 24 h of birth; and
- •able to initiate the protocol within 72 h of birth and continuously provide adequate colostrum until the end of the protocol.
排除标准
- •Death within 48 h;
- •severe birth asphyxia (defined as umbilical artery/first-hour arterial blood gas pH < 7.0);
- •birth with severe gastrointestinal malformations (e.g., intestinal atresia, tracheoesophageal fistula, malrotation of the intestines, and Hirschsprung's disease);
- •prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases; and
- •maternal substance abuse or contraindications to breastfeeding (e.g., HIV).
结局指标
主要结局
The incidence rate of extrauterine growth restriction (EUGR) among participants at the time of hospital discharge
时间窗: The time frame extends from the first day of hospitalization to the day of discharge, covering the entire inpatient stay, with an average duration of 1.5 months.
EUGR is defined as the situation where the growth measurement (weight, head circumference, or body length) taken at the time of discharge is less than or equal to the 10th percentile of the predicted value based on the Fenton 2013 growth chart.
次要结局
- The inter-group variances in the gut microbiota of participants subsequent to the intervention(The seventh day after birth)
- Intergroup difference in the time to regain birth weight(Up to 10 days, with an average of 5 days.)
- The incidence rate of bronchopulmonary dysplasia(The time frame extends from the first day of hospitalization to the day of discharge, covering the entire inpatient stay, with an average duration of 1.5 months.)
研究者
Na Wang
Principal Investigator
Suqian First Hospital