Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 91
- 试验地点
- 3
- 主要终点
- Cardiorespiratory stability
研究概览
简要总结
The World Health Organization recommend all stable low birth weight neonates to have Skin-to-skin-Contact (SSC) after birth. Intermittent SSC is used in Sweden in neonatal units. Observations indicate that SSC makes neonates feel good. However, there is limited research done on SSC treatment on neonates born prior to week 33.
The aim of this study is to investigate whether Skin-to-skin-Contact (SSC) leads to an improved physiological stabilization, altered epigenetic profile and improved longterm psychomotor outcome in neonates born in gestation age between week 28+0 - 32+6. This is a parallel, two-arm, multicentre, randomized controlled superiority trial. The two arms to be compared are a) immediate SSC with one parent/caregiver continous during the first 6 hours after birth and as much as possible during the first 72 hours, and b) conventional method of care during the same time.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born in gestation week plus days 28+0 - 32+
- •Born at maternity ward at study center
- •Consent from parents/caregivers
- •Parent or caregiver or substitute are available to start skin-to-skin Contact during the first hour of life.
排除标准
- •Born outside the hospital
- •Triplets or more
- •Known malformation which will require immediate surgical action
- •On-going resuscitation or intensive Medical care (mechanic ventilation or inotropy) after the first lifespan
- •* Known congenital infection
- •Parent/care giver can not communicate in Swedish/Norwegian or English
- •Not suited for the study for other reasons (according to the principal investigator)
结局指标
主要结局
Cardiorespiratory stability
时间窗: After six hours
Using the Stability of the CardioRespiratory system In the Preterm-score (SCRIP-score). A higher SCRIP score indicates greater physiological stability
次要结局
- Need for respiratory support(After 3 months)
- Time to Full enteral nutrition(After 3 months)
- Need for surfactant(After 3 months)
- Heart Rate Variability(Up to 3-4 months)
- Weight gain(Up to 12 months)
- Need of Continuous positive airway pressure(After 3 months)
- Need for oxygen(After 3 months)
- Body temperature(At 0 hour (postpartum), 1, 2, 3, 4, 5 and 6 hours)
- Sepsis episodes(After 3 months)
- Telomere profiling in blood samples(Up to 24 months)
- Microbiota(0-6 hours, 72 hours, 3-4 months, 12 and 24 months. Mother is tested at 0-6 hours and partner with skin swabs at 0-6 hours.)
- Structural and functional maturation of the infant brain(At term age)
- Number of Antibiotic treatment(After 3 months)
- Time in use of Nasogastric tube feeding(After 3 months)
- Epigenetic profiling in buccal cells(Up to 24 months)
- Telomere profiling in buccal cells(Up to 24 months)
- Maturation of EEG-pattern(Postnatal day 4-10 and postmenstrual age of 40-42 weeks)
- Time to recovered birth weight(After 3 months)
- Epigenetic profiling in blood samples(Up to 24 months)
- Maternal brain responsiveness(At 4 months)
- Bonding and interaction between parent and child(At 3-4 months)
- Maternal-Child physiological attunement in stress regulation(In the morning and in the evening at the day of discharge, At the day of discharge before and after diaper change, at 3-4 months, at the same day as Still Face-test before and after, at 12 months.)
- Status of Breast-feeding(Up to12 months)
- Parents' experiences(Up to 12 months)
- Neuro Behaviour of Child(At term age, at 3-4, 12 and 24 months)
研究者
Björn Westrup, MD PhD
Co-director of Karolinska NIDCAP Training and Research Center
Karolinska Institutet