IMPACT OF SKIN-TO-SKIN CONTACT ALERT DEVICE "KANGA SURAKSHA" ON PARENT COMPLIANCE TO KANGARO MOTHER CARE IN LOW-BIRTH-WEIGHT BABIES BETWEEN 1.5-2.5KGS COMPARED TO CONVENTIONAL KANGARO MOTHER CARE A ONE YEAR HOSPITAL BASED RANDOMIZED CONTROL TRAIL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- This KANGA SURAKSHA device will increase complainace to KMC for more than 10hours The study will be conducted over a span of one year
研究概览
简要总结
Kangaroo mother care (KMC), sometimes called skin-to-skin care, is a technique of
newborn care where babies are kept skin-to-skin with a parent, typically their mother. It
is most used for Low Birth-Weight preterm babies. It ensures warmth to preterm/LBW
improves breast feeding, prevents infection and it also reduces hospital stay.
Participation of your child will help us to assess the compliance to kangaroo mother care
which promotes better weight gain, early breast feeding and early discharge.
We will divide into two groups in which one will receive "KANGA SURAKSHA" device and
other group will receive routine kangaroo mother care.
In the study you may be included in any one of the groups. If you are selected in the
intervention group you will receive the "KANGA SURAKSHA" device.
As a mother you may not practice KMC properly, you may not know when the baby
becomes cold, hence in this study the device detects hypothermia, which will alert you
to put your baby in skin-to-skin contact. This device monitors whether the baby is in
skin-to-skin contact or not, weight of the baby and checks temperature with an alarm.
This information will be obtained on phone, which will help us to monitor your
compliance to KMC and alert you when required. By practicing KMC for a longer time,
we expect that you will be able to practice breastfeeding better and in turn your baby
gains better weight. Practicing KMC will also help in early discharge.
However, we will be calling you for regular follow ups every week to monitor the weight
gain, breastfeeding, and other problems which we do routinely for all the babies in KMC.
This monitoring will be done till the baby attains 2.5kgs or 40 weeks. You will be given a dairy to note down the no. breast feeds, mode of feeding, temperature and duration of
KMC being practiced.
If you are selected in the control group you will be providing conventional KMC care to
your baby. You will be manually monitoring temperature and weight gain of your baby
as per the instructions of health care providers.
Routine monitoring of the babies in both the groups will be done by the health care
providers (Doctors and nurses) as a part of NICU care for preterm and Low birth weight
babies with KMC.
As in the intervention group weekly follow up of the babies in the control group will be
done in the KMC clinic. A self-reporting dairy similar to the interventional group would
be provided to the mothers, data of which would be collected on scheduled follow ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Day(s) 至 40.00 Day(s)（—）
- 性别
- All
入选标准
- •Impact of skin to skin contact alert device KANGA SURAKSHA on parent complaince to KMC in low birth weight babies between 1.5-2.5kgs compared to conventional kangaro mother care a one year hospital based RCT.
排除标准
- •1 Infants not clinically stable or who had major congenital malformation will be excluded 2 Mother with debilitating ilness who would not be able to provide KMC 3 Those who are not willing to give consent are also excluded from study.
结局指标
主要结局
This KANGA SURAKSHA device will increase complainace to KMC for more than 10hours The study will be conducted over a span of one year
时间窗: The study will be conducted over a span of one year
次要结局
- 1 will promote better weight gain in LBW babies compared to conventional kangaroo mother care(2 will improve breast feeding in babies compared to conventional kangaroo mother care)