NCT03079284已完成不适用
The Effects of Holding on Stress and Bonding in Mother-Infant Dyads During Therapeutic Hypothermia
Alexa Craig2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3月20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
- 10
- 试验地点
- 2
- 主要终点
- Frequency of Adverse Events (Safety)
研究概览
简要总结
Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period. This is a safety study that will assess whether or not there is an increase in adverse event frequency in infants that are held during hypothermia. Parents and NICU nurses will be given a questionnaire after holding is complete investigating their feelings on maternal-infant bonding and safety of the holding protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 24 Hours 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant must have a gestational age of greater than or equal to 35 weeks
- •Infant must be undergoing treatment with therapeutic hypothermia
- •Infant must be without seizures in the first 24 hours of treatment based on EEG
- •Infant must be clinically stable on bubble CPAP, nasal cannula, or no respiratory support.
- •Informed consent must be signed by the mother at Maine Medical Center
排除标准
- •Infant is intubated
- •Infant is being treated with inhaled nitric oxide
- •Presence of Persistent Pulmonary Hypertension of the Newborn
- •Presence of seizure on EEG
- •Use of vasopressors or paralytic agents
- •Presence of chest tubes, wound vacuums, or drains
- •Neonatal abstinence syndrome
结局指标
主要结局
Frequency of Adverse Events (Safety)
时间窗: 3 days
Assess the frequency of adverse events during the holding intervention including unintentional rewarming of the infant, dislodged infant catheters (umbilical arterial/venous lines, urinary catheter, iv) or infant intolerance of holding due to vital sign instability.
次要结局
- Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.(3 days)
- Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.(3 days)
- Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.(3 days)
- Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...(3 days)
- Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...(3 days)
- Qualitative Experience of Nurses: I Would Like to See Holding During Cooling Become a Standard Practice in Our NICU, so Long as the Infant is Otherwise Medically Stable.(3 days)
- Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…(3 days)
- Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:(3 days)
- Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:(3 days)
- Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:(3 days)
- Qualitative Experience of Mothers: After Holding my Baby, I Feel:(3 days)
- Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia(3 days)
- Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable(3 days)
- Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:(3 days)
- Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:(3 days)
- Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:(3 days)
- Qualitative Experience of Mothers: After Holding my Baby, I Feel:(3 days)
- Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia(3 days)
- Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable(3 days)
- Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.(3 days)
- Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.(3 days)
- Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...(3 days)
- Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...(3 days)
- Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.(3 days)
- Qualitative Experience of Nurses: I Would Like to See Holding During Cooling Become a Standard Practice in Our NICU, so Long as the Infant is Otherwise Medically Stable.(3 days)
- Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…(3 days)
研究者
Alexa Craig
Assistant Professor of Pediatrics
MaineHealth
研究点 (2)
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