Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion (SDF) With Sling Versus Traditional Prone Position With Headband During Skin-to-skin Care Session
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Daily duration of skin-to-skin during postnatal hospitalisation
研究概览
简要总结
This is a prospective, controlled randomized study designed to compare the effects of two methods of skin-to-skin positioning of preterm infants: the prone positioning method currently used (according to the World Health Organization's recommendations) and the recent "sustained diagonal flexion" method (SDF) on the daily duration of skin-to-skin contact.
详细描述
This is a prospective, controlled, randomized, non-blinded trial, recruiting premature infants between 27- 34 weeks of gestational age during the first 4 days of life.
80 parent-infant dyads will be recruited in the Department of Neonatology (GA between 27 and 34 weeks) and randomly divided in two groups. Each dyads will be assigned to one of the two skin-to-skin positions.
The study aims to investigate if the sustained diagonal flexion method (SDF) provides additional benefits for both the child and their parents, such as increase in daily skin-to-skin time and its continuation after discharge.
The investigators will analyze the daily duration of skin-to-skin, the cardiorespiratory stability of the child (number of incidents recorded by standard monitoring), the presence of pain during: installation /skin-to-skin/ after the return to the incubator, the continuation of skin-to-skin, breastfeeding after discharge, the risk of postpartum depression in the mother, parental stress, joint mobility and muscle tension of the child and their parents, and also the comfort and satisfaction with the type of skin-to-skin.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Hours 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature infant born between 27 and 34 weeks of gestational age
- •Aged between 24 hours and maximum 4 days at the beginning of the study
- •Approval from the neonatologist in charge of the patient to participate in the study
- •Informed consent of the parents to participate in the study
- •At least one of the two parents must have a good knowledge of French.
排除标准
- •Infant with severe secondary neurological or medical conditions, e.g., neurological deficits due to vascular hemorrhage (grade III or IV)
- •Infant or parent who requires or has required surgery during their neonatal stay
- •Parent who suffers from a physical disability or severe psychological illness, a psychosocial situation that does not allow skin-to-skin care
- •Infant with an arterial line
结局指标
主要结局
Daily duration of skin-to-skin during postnatal hospitalisation
时间窗: during hospitalisation
Investigate the effect of skin-to-skin position of premature infants in supported diagonal flexion (SDF) by a sling on daily duration of skin to skin contact during hospitalization (Measured in minutes per day. )
Continuation of skin-to-skin after discharge
时间窗: 6 months
Time spent in a sling by 6 months of age. (Measured in minutes per day)
次要结局
- Comfort-Behavior pain scale (Comfort-B) score measuring pain and comfort of the premature infant before during and after skin-to-skin contact(3-12 days)
- Parental psychological wellbeing - French version of the Parental Stressor Scale (PSS)(1 day-22 days)
- Breastfeeding at discharge and at 1, 3, 6 month of age(6 months)
- Physiological parameters via Newborn Infant Parasympathetic Evaluation (NIPE) scores(3-22 days)
- Cardiovascular stability of the infant(3-12 weeks)
- Parental psychological wellbeing - the Edinburgh Postnatal Depression Scale (EPDS)(1 day-22 days)
- Physiological parameters via Stability of the Cardiorespiratory System in Premature Infants (SCRIP) score(3-22 days)
- Premature Infant Pain Profile-Revised (PIPP-R) pain score measuring pain and comfort of the premature infant before during and after skin-to-skin contact(3-12 days)
- Position of joints and muscle tone observed by osteopath or physiotherapist and evaluated by joint, posture and muscle tone assessment -JPMA established by the investigators(2 days-12 weeks)
研究者
Dorottya kelen
Head of Neonatal Unit
Erasme University Hospital