Efficacy and safety of Nourishing Baby Massage oil in growth, development, muscle strength and behavioral assessment of Neonates - An open labeled, randomized, multi-centric, comparative, prospective, clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- Marico Ltd.
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Changes in anthropometrical measurements from baseline to each follow visit and against control.
研究概览
简要总结
It is an open labeled, randomized, multi-centric, comparative, prospective, clinical study to evaluate efficacy and safety of Nourishing Baby Massage oil in growth, development, muscle strength and behavioral assessment of Neonates. The study will be carried out at 3 to 4 centers in India. Parents/ legal guardian in group I will be asked to do massage of their neonate with Nourishing Baby Massage oil twice daily for 3 months and Parents/ legal guardian in group II will be asked to do massage of their neonate with marketed preparation oil twice a day for 3 months. The primary objectives of the study will be to assess changes in anthropometrical measurements and Z score from baseline to each follow visit and against control. The secondary objectives of the study will be to assess changes in orientation state, effect on mood, activity status, cooperation for massage and fidgeting/nervous behavior of subjects prior to massage, during massage and post massage, changes in sleep pattern, changes in Softness / suppleness / smoothness of skin, changes in muscle and bone strength, time taken for major milestones, changes in food intake, changes in episodes, severity and duration of illness (infections or allergies), changes in skin condition, overall change in growth and behavior by investigator and parents / legal guardian, adverse events and vitals and tolerability of oil massage as per the parents / legal guardian and investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Full term (born after 37 weeks of gestation) and preterm (born prematurely prior to 37 weeks gestation), either normal or C-Section, neonates (till the age of 28 days) weighing 2500 grams at the time of recruitment or more will be included if they fulfill the following inclusion criteria: 1.Apgar score >7 at 1 and 5 minutes with no resuscitation required at birth.
- •2.Medically stable with no requirement of drugs, or any interventions/procedures other than Nutraceuitcal / health supplement.
- •3.Parents of the babies willing to sign an informed consent.
排除标准
- •1.Neonates not on breast feed 2.Sick babies and those babies who have congenital anomalies or neuromuscular disorders.
- •3.Babies with muscular trauma or skin infections.
- •4.Parents of the Babies not willing to come for follow-up when required 5.Babies participating in any other clinical trials.
- •6.Known hypersensitivity to any of the ingredients of study product 7.Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
结局指标
主要结局
Changes in anthropometrical measurements from baseline to each follow visit and against control.
时间窗: Screening/ Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90)
2. Changes in Z score from baseline to each follow visit and against control
时间窗: Screening/ Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90)
次要结局
- 1.Changes in orientation state, effect on mood, activity status, cooperation for massage and fidgeting/nervous behavior of subjects prior to massage, during massage and post massage(2.Changes in sleep pattern)