“Impact of early initiation of Kangaroo Mother Care on Moderately Sick Neonates Weighing ≤ 1500 Grams: A Randomized Controlled Trial in a tertiary care hospital.â€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To study the effect of early KMC in babies weighing ≤ 1500 grams on hospital stay compared with standard care.
研究概览
简要总结
Kangaroo mother care (KMC) is a very effective intervention for improving outcomes among preterm low birth weight neonates. KMC compared to standard of care has reduced neonatal mortality in Low Birth Weight (LBW) neonates by 36%. Early Skin to Skin Contact (SSC) among term neonates has shown beneficial effects on breastfeeding one to four months post-birth, blood glucose, infant crying, and infant temperature stability.
However, studies regarding KMC given to very preterm neonates especially neonates weighing ≤1500 grams, initiated early during NICU stay are limited. This period is very fragile especially when the neonates are on respiratory support and are prone to hemodynamic instability and as result vulnerable to higher morbidities and mortality.
We aim to conduct a randomized control trial to find out the outcome in moderately sick neonates weighing ≤1500 grams with early initiation of KMC vs. those with no early KMC (standard care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Day(s) 至 18.00 Month(s)（—）
- 性别
- All
入选标准
- •Preterm babies weighing ≤ 1500 grams Age: within 7 days of life Mother or any other caregiver available and willing to provide KMC Babies with stable cardio-respiratory parameters i.e. requirement of one inotrope, ≤2 apnea episodes in 24 hours, babies on respiratory support (MAP < 8 cms and FIO2< 60%) both invasive and non-invasive ventilation.
排除标准
- •1.Neonates with major congenital anomalies and syndromic babies.
- •2.Neonates on high-frequency ventilation.
结局指标
主要结局
To study the effect of early KMC in babies weighing ≤ 1500 grams on hospital stay compared with standard care.
时间窗: AT 40 WEEKS OF GESTATIONAL AGE | AT 18 MONTHS OF AGE
次要结局
- 1. To study the incidence of sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, intraventricular hemorrhage, apnoea, and feed intolerance.(2. To study the growth at 40 weeks corrected age in both the groups for extra-uterine growth retardation (EUGR).)