NCT00531492已完成不适用
Randomized Controlled Trial of Continuous Skin to Skin Care (Technique Kangourou: TK) for Low Birth Weight (LBW) Infants and Their Mothers at University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM), Madagascar
Foundation for Advanced Studies on International Development1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2007年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Mortality within 28 days after birth
研究概览
简要总结
The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country.
For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours) contact between LBW infants and their mothers or any other people who substitute mothers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight (BW) < 2500g
- •Delivery at maternity of CHUM (Birth < 24 hours)
- •Without serious congenital malformation
- •Sat O2 >=95％, HR > 100 / min, RR < 60 / min, Capillary refilling time < 3 sec
- •The mother and the family are motivated to practice TK.
- •The mother and the family available to practise TK should be healthy.
排除标准
- •Apnea of prematurity >20 sec
- •With intravenous infusion
结局指标
主要结局
Mortality within 28 days after birth
时间窗: within 28 days after birth
次要结局
- Mortality within 6 months or 1 year after birth(within 6 months or 1 year)
- Mobility within 6 months or 1 year after birth(within 6 months or 1 year)
- Mobility within 28 days after birth(within 28 days after birth)
- Mortality and Mobility within 28 days after birth(within 28 days after birth)
- Difference of (Baby's) loss in weight within 2 days(within 2 days)
- Difference of (Baby's) Body weight of 14th day after birth(14th day after birth)
- Difference of (Baby's) Body weight of 28th day after birth(28th day after birth)
- Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃）(Within 28 days after birth)
- Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)(within 28 days after birth)
- Incidence of apnea during hospitalisation (> 20 sec)(within 28 days after birth)
- Incidence of desaturation during hospitalisation ( <87%)(within 28 days after birth)
- Length of hospitalisation(within 28 days after birth)
- Discharge within 7days after birth(within 7days after birth)
- Mortality and Morbility within 6 months or 1 year after birth(within 6 months or 1 year)
- Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃）(Within 28 days after birth)
研究者
Shuko Nagai
Groupe d'Etude de la Technique Kangourouà
Foundation for Advanced Studies on International Development
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Effects of Baby Massage on Parenting Stress and Attachment in PrematurePremature BirthNCT04255797Chung Shan Medical University84
已完成
2 期
Mid and Standard Frequency Ventilation in Infants With Respiratory Distress SyndromeVentilator-Induced Lung InjuryRespiratory Distress SyndromePreterm InfantBronchopulmonary DysplasiaNCT03231735University of Alabama at Birmingham60
已完成
不适用
Randomized Controlled Trial Investigating Optimal Treatment for Chronic Subdural HematomaChronic Subdural HematomaNCT02655445Universitair Ziekenhuis Brussel250
已完成
不适用
Study of the Intervention Effect of Self-help Training Camps in Promoting Mental Health Among Perinatal WomenMental HealthPerinatal DepressionPerinatal DepressionPerinatal DepressionNCT06405932Fangbiao Tao1,691
进行中（未招募）
不适用
Cervical Radiculopathy TrialCervical RadiculopathyNCT03674619Oslo University Hospital180