To evaluate the beneficial effect of oral application of colostrum or mothers own milk in preterm baby A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The serum IgA level values in two groups
研究概览
简要总结
Background: Premature babies are at higher risk for getting infection and necrotizing enterocolitis leading to significant morbidity and mortality. Mothers own milk contain protective enzymes and immunoglobulins which provide antimicrobial, anti-inflammatory and can lower down the rates of infection and necrotizing enterocolitis. Oropharyngeal administration of own mother’s milk may raise serum IgA level which improve the overall outcome of preterm babies.
Aim and Objectives: To estimate the salivary IgA level in babies and to corelate the incidence of sepsis and necrotizing enterocolitis with oral application of colostrum and mothers’ own milk (MOM).
Design of study: Randomized control trial. Setting: NICU, JNMC Sawangi Meghe. Duration: 1 year
Methodology: All inborn babies less than 32 weeks of gestation requiring CPAP and Ventilation and not receiving feed will be included in study. Babies will be allocated in two groups by randomized selection. Interventional group will be applied colostrum to oral mucosa and will receive 0.2 ml of own mother’s own milk via oropharyngeal administration. Control group babies receive a placebo (0.2 ml sterile water) following the same protocol. The serum IgA level will be estimated after 7 days in all babies. The incidence of septicemia, NEC and total stay will be noted down during course of hospital stay.
Data collection and analysis: Demographic information will be collected and detailed perinatal history will be noted. The septicemia parameters, abdominal girth, feed intolerance and x ray findings will be noted. The serum IgA levels will be calculated and compared in two groups. The data will be analysed by the STATA 10 software. The chi- square and Fischer’s exact two tail test will be used to study the frequency, odd ratio and p value < 0.05 will be considered significant.
Key Words: Colostrum, Mothers own milk, Septicemia, Immunoglobulin, Necrotizing enterocolitis,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 45.00 Day(s)（—）
- 性别
- All
入选标准
- •Sick babies with less than 32 weeks of gestation requiring CPAP or ventilation who is not receiving feed directly.
- •Mother plans to pump and provide milk for babies admitted in NICU.
- •NICU admissions less than 24 hrs.
- •of life and inborn babies 4) Ability to begins protocol within 96 hours of life.
排除标准
- •Babies having
- •birth asphyxia (cord ph/arterial ph less than7)
- •Parents not giving consent.
结局指标
主要结局
The serum IgA level values in two groups
时间窗: Oral application of milk - 24 hours | Serum IgA blood values at 7 days of life | Septic Screening at 7-10 days | Discharge or death at the time of discharge 4-6 weeks
The incidence of Ventilatory associated pneumonia
时间窗: Oral application of milk - 24 hours | Serum IgA blood values at 7 days of life | Septic Screening at 7-10 days | Discharge or death at the time of discharge 4-6 weeks
次要结局
- Total days of hospital stay(The incidence of septicaemia and necrotising enterocolitis)
研究者
Dr Mahaveer Singh Lakra
Datta Meghe Institute of Higher Education and Research,Sawangi Meghe.