Management of Healthy Newborn's Body Temperature With the Use of Blanket: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 776
- 试验地点
- 2
- 主要终点
- Newborn's body temperature at the end of skin-to-skin contact
研究概览
简要总结
At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.
Hypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).
One of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.
To date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.
Some studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.
The aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth.
详细描述
This study is a prospective, randomized controlled trial design which involves the use of two care interventions (experimental vs standard of care) to prevent heat loss of healthy newborns in the delivery room during contact skin to skin after birth.
Study population includes newborns born by natural birth with a gestational age greater than or equal to 37+0 weeks.
Newborns will be randomly assigned to receive: 1) a thermal blanket (experimental group) , or 2) a bed wetting mat and cotton sheet (standard of care group) that cover them during the skin-to-skin contact after birth.
At birth all newborns will receive the same care required by local procedures.
Research hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mothers' age over 18 years and good comprehension of Italian language;
- •Signed informed consent of the mother.
- •For newborn
- •Informed consent signed by both parents, or in the case of a single-parent family, by mother
- •Gestational age at birth greater than or equal to 37+0 weeks
- •Newborns from singleton pregnancies;
- •Both male and female newborns;
- •Newborns who will be born from vaginal birth.
排除标准
- •Mothers who do not want to carry out skin-to-skin contact;
- •Mothers who do not understand/speak the Italian language;
- •Mothers who need assistance procedures that hinder skin-to-skin contact.
- •For newborn
- •Newborns whose parents decline participation in the study;
- •Newborns with major congenital anomalies (heart, brain, metabolic, gastrointestinal);
- •Newborns born via cesarean section;
- •Newborns whose parents are under 18 years old, in the case of a single parent the mother who is under 18 years;
- •Newborns requiring neonatal resuscitation after birth with obstruction of the skin-to-skin contact.
研究组 & 干预措施
Interventional group
All the enrolled newborns will make the skin-to-skin contact with the use of a thermal blanket after birth.
干预措施: Interventional group (Other)
Standard of care group
All the enrolled newborns will make the skin-to-skin contact according to local procedure after birth.
干预措施: Standard of care group (Other)
结局指标
主要结局
Newborn's body temperature at the end of skin-to-skin contact
时间窗: At the beginning and the end skin-to-skin contact, up to three hours after birth.
Newborn's body temperature will be measured at the beginning and the end of skin-to-skin contact with a digital thermometer placed in axillary location. Newborn's body temperature at the end of kin-to-skin contact will be compared between two groups.
次要结局
- Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU)(At discharge from the nursery, measured up to 1 week.)
- Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery(At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.)
- Newborns' proportion with moderate hypothermia (temperature 36.0 - 36.4°C) at the end of skin-to-skin contact and at arrival in the nursery(At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.)
- Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery(At the end of skin-to-skin contact and at arrival in the nursery, up to six hours after birth.)
- Newborns' average temperature one hour after arriving at the nursery(At arrival in the nursery, up to six hours after birth.)
- Duration of nursery stay(from birth until discharge, measured up to 1 week.)
- Newborns' proportion affected by respiratory distress syndrome(At discharge from the nursery, measured up to 1 week.)
- Duration of skin-to-skin contact(From the beginning until the end of skin-to-skin contact, up to three hours after birth.)
- Newborns' proportion exclusively breastfed at discharge(At discharge from the nursery, measured up to 1 week.)
- Type of breastfeeding at discharge(At discharge from the nursery, measured up to 1 week.)
- Newborns' proportion with hypoglycemia during hospitalization(At discharge from the nursery, measured up to 1 week.)
- Newborns' weight loss at discharge(At discharge from the nursery, measured up to 1 week.)
- Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery(At the arrival in the nursery, up to six hours after birth.)
- Mortality before discharge from hospital(At discharge from the nursery, measured up to 1 week.)