Impact of Sthira kshirpaak on lactogenesis II of nursing Mothers and on weight velocity of their neonates A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lactogenesis II time
研究概览
简要总结
Title
Impact of Sthira Kshirapaak on lactogenesis II in nursing mothers and on weight velocity of their neonates. A randomized controlled trial.
Introduction
Lactogenesis II is referred to as milk coming in which represents the onset of copious milk secretion, breast fullness and increased volume.
Need of the Study
Delayed Lactogenesis II with a global incidence of 17 to 44 percent has significant clinical implications on weight and growth outcomes of neonates.
Objectives
Primary
To assess the effect of Sthira on the duration of Lactogenesis II.
Secondary
To assess the impact of Sthira Kshirapaak administered to mothers on the weight velocity of neonates.
Materials and methods
Setting
Multi centric trial
Procedure
The dyad of mothers and neonates born in the maternity ward of the study centers screened for inclusion and exclusion criteria and willing to give an informed consent to participate in the trial will be registered.
PIS will be given to the participants and written informed consent/ assent will be taken and they will be randomized into 2 groups.
Assessment
Baseline data and periodic assessments will be done at the specified intervals. ie. Daily from day 1 of Post-partum until day 5 postpartum.
Objective Parameters
Expressed milk volume
Latch Score
Neonatal weight gain or loss per day
Test Weight
Subjective parameters
in mothers
based on Maternal perception of breast feeding
in neonates
based on
Satiety
urine frequency
stool frequency
etc.
Intervention
The Trial group will receive Sthira and Sita 6 grams each to be processed with milk while the Control group will receive Brown Cane Sugar and Sita 6 grams each also to be processed with milk. Both the intervention as well as placebo will have identical packing.
Duration of medication
5 days
Duration of the study
7 days
Ethical considerations
The study will commence after obtaining permission from the institutional ethical committee and after CTRI approval, following the GCP guidelines.
Statistical Analysis
Will be done using appropriate software.
References
Reference management systems will be used.
Conflicts of interest
Conflicts of interest if any shall be declared.
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
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •For mothers: Registered Primi gravida mothers who have taken ANC.
- •In Reproductive age group of 15-49years.
- •Clinically Stable For Neonates: Live Singleton babies of either sex With birth weight appropriate for Gestational age Clinically Stable.
排除标准
- •For mothers: Contra-indicated to breast feed Those under medications that affect the study results Those with co-existing medical conditions that adversely affect lactation Those with major anatomical breast anomalies Critically ill For neonates Those with birth weights less than 2500grams or more than 3500 grams those with Gestational Age less than 37 weeks or greater than 42 weeks those with medical conditions which necessitate weaning or total parental nutrition Those with major congenital anomalies Critically ill neonates.
结局指标
主要结局
Lactogenesis II time
时间窗: Postpartum Day 1 to day 5 daily assessment
Latch Score in hours
时间窗: Postpartum Day 1 to day 5 daily assessment
次要结局
- Neonatal weight loss or gain in grams(7 days)
研究者
Dr Mithila Amin Shreeniwas
DY Patil School of Ayurveda