The association of the knowledge of kangaroo mother care among mothers of moderate and late preterm neonates and infant weight gain- A single blinded parallel 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
- 86
- 试验地点
- 1
- 主要终点
- The association of the knowledge of Kangaroo Mother Care among mothers of moderate and late preterm and weight gain of the preterm infant.
研究概览
简要总结
A Single blinded parallel- randomized controlled trial will be conducted in Government Ladygoschen Hospital in Mangalore.The study participants satisfying the inclusion criteria will be approached, and the nature and objectives of the study will be explained in a language understood by them.
After obtaining the consent, the subjects (mothers) will be divided in to two groups.Each group will have two arms and block randomization will be used to divide the group. Block size of 6 will be used, with the possibility of 56 permutations and combinations. To reach the sample size of 86, a total of 15 such blocks will be used in a randomly generated sequence so that an equal number of participants will be allocated in both the groups. For example:(ABABAB/AABBAB/ABBABA/BBBAAA and so forth) For a block size of 6, the sequence will be generated.Opaque envelope method will then be used for concealment of allocation into the intervention groups.
(i) Intervention Group: The participants in the Intervention group will undergo the standard protocol of care where the explanation about KMC will be given as per the hospital protocol. This group of mothers will also be educated by principal investigator where the mother will be explained about KMC in detail in a language understood by them, using flipcharts, in a 30- minute training sessions. These sessions will be conducted as one to one training sessions and all the queries of the participants will be cleared. After 48 hrs, the assessment of knowledge, attitude, and practice of KMC will be tested by a validated questionnaire. If post assessment score is less than 60%, the mother will be reinforced on the factors the mother was lacking. The next day, the Kangaroo mother care skills of these mothers will be assessed by a trained maternity nurse or social health worker who is blind to this study. All the mothers will be enquired about adherence to KMC during the follow up visits.
(ii) Control Group: The participants in the Control group will have standard protocol of explanation about KMC as per hospital protocols. After 48 hrs, assessment of mother’s knowledge, attitude, and practice about KMC, will be evaluated by a validated questionnaire. The next day, the Kangaroo mother care skills of these mothers will be assessed by a trained maternity nurse or social health worker who is blind to this study. All the mothers will be enquired about adherence to KMC during the follow up visits.Anthropometry of all neonates will be taken in the following manner and at the following intervals:
(i) Weight: All neonates will be weighed on electronic baby weighing scale (SAMSO) with sensitivity of 10 grams and will be plotted on INTERGROWTH 21 Charts at the following intervals:
- Immediately after birth,
- On the day of initiation of KMC
- At discharge
- At follow up at 2 weeks and 6 weeks post discharge
(ii) Length: Length of all neonates will be measured using Infantometer (MCP Infantometer) on the day of delivery and on the day of initiation of KMC and these will be plotted on INTERGROWTH 21 Charts at the following intervals:
- Immediately after birth,
- At discharge
- At follow up at 2 weeks and 6 weeks post discharge
(i) Head circumference: Head circumference of all neonates will be measured by using a non-Stretchable measuring tape and these will be plotted on INTERGROWTH 21 Charts at the following intervals:
- After 24 hours of delivery
- At discharge
- At follow up at 2 weeks and 6 weeks post discharge
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •Stable Moderate and Late Preterm neonates with gestational age more than 32 weeks and their mothers.
- •Mothers who are willing to give exclusive breastmilk feeds for six months.
- •Neonates who are on exclusive breastmilk with calorie consumption of 150-170 kcal/kg/day.
排除标准
- •Haemodynamically unstable neonates who unfit for KMC during study period.
- •Neonates who are admitted in NICU for more than 48 hours.
- •Mothers who are unable to give KMC as they are critically ill.
- •Mothers with lactational failure.
- •Mothers who are unable to comply with follow up.
结局指标
主要结局
The association of the knowledge of Kangaroo Mother Care among mothers of moderate and late preterm and weight gain of the preterm infant.
时间窗: 1. within 48 hours | 2. at 6 weeks
次要结局
- 1. To assess the knowledge of Kangaroo Mother Care among mothers of preterm neonates.(2. To compare the knowledge retention about Kangaroo mother Care in mothers of preterm neonates between the educational intervention group and control group.)
研究者
Dr TV Sai Krupa
Kasturba medical college, Mangalore