The Impact of Holding During Therapeutic Hypothermia on Saliva Oxytocin and Cortisol Levels in Mother-Infant Pairs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MaineHealth
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in the level of oxytocin in maternal saliva
研究概览
简要总结
This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment. Mothers have reported that not being able to hold their baby during this time is stressful. Additionally, it is known that holding has many benefits for mothers' and babies' psychological and physical health.
Therapeutic hypothermia is the standard of care. The experimental interventions of this study are to have mothers hold their babies during this treatment, collect saliva samples from mothers and babies, and test the saliva samples for the hormones cortisol and oxytocin. The investigators will test saliva of infants and their mothers before and after holding. The investigators hope to demonstrate decreased cortisol, a marker for stress, and increased oxytocin, a marker for bonding, in infants and mothers while they are held during therapeutic hypothermia.
详细描述
The inability to hold an infant being treated with therapeutic hypothermia in the neonatal intensive care unit has been subjectively reported by ours and other research groups as a significant source of stress for parents. The investigators aim to assess the impact of holding on endocrinological markers of stress and bonding. Specifically, the investigators plan to collect salivary cortisol and oxytocin levels from infants undergoing therapeutic hypothermia and their mothers prior to and immediately after a 30-minute holding period.
The investigators hypothesize that measurable increases in salivary oxytocin levels, coinciding with the reported qualitative increased levels of bonding, will be observed after the holding period. The investigators anticipate the reported stress reduction after holding to be quantified by measurable decreases in salivary cortisol levels. The investigators hypothesize these hormone changes will be present in both the mother and the infant when compared to samples taken without the holding intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 24 Hours 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age at birth of 35 weeks or greater
- •absence of clinical or electrographic seizures during the first 24 hours of therapeutic hypothermia
- •designation as "clinically stable" by the attending neonatologist on service
- •respiratory status of: room air, nasal cannula, continuous positive airway pressure or intubated on conventional ventilator
排除标准
- •designation as "clinically unstable" by the a member of the medical team
- •use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn
- •high frequency oscillator ventilation
- •presence of electrographic seizures
- •use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains
- •in utero opiate exposure
结局指标
主要结局
Change in the level of oxytocin in maternal saliva
时间窗: 30-minutes
To compare the change in the level of oxytocin in maternal saliva between two conditions; one assessing the difference between oxytocin levels before and immediately after a 30-minute period of holding during therapeutic hypothermia compared to the second condition in which pre and post-levels of salivary oxytocin surrounding a 30-minute period of "not holding" are obtained.
次要结局
- Subjective nurse reports(Immediately after 30-minutes of holding)
- Change in the level of cortisol in maternal saliva(30-minutes)
- Change in the level of oxytocin and cortisol in infant saliva(30-minutes)
- Comparison of infant temperature before, during and after holding(30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.)
- Comparison of infant oxygen saturation before, during and after holding(30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.)
- Subjective maternal reports(Immediately after 30-minutes of holding)
- Comparison of infant blood pressure before, during and after holding(30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.)
- Comparison of infant heart rate before, during and after holding(30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.)
研究者
Alexa Craig
Attending Pediatric Neurologist
MaineHealth